Animas Corp.
Frazer, PA, US
Animas Corp. appears in FDA device records in Frazer, PA. FDA records list 10 510(k) clearances between and , 53 PMA records and no registered establishments. As of , FDA records show 28 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Animas Corp. between 2000 and 2008. The busiest year on record is 2002, with 2. The most recent is 2008, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | LZG | Substantially Equivalent | |
| K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE | MRZ | Substantially Equivalent | |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | LZG | Substantially Equivalent | |
| K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP | LZG | Substantially Equivalent | |
| K032257 | MODEL IR 1200 INSULIN PUMP | LZG | Substantially Equivalent | |
| K022394 | EZMANAGER PLUS | LZG | Substantially Equivalent | |
| K021700 | ANIMUS EZSERTER INFUSION SET INSERTER | KZH | Substantially Equivalent | |
| K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO | LZG | Substantially Equivalent | |
| K012754 | EZ SET INFUSION SET | FPA | Substantially Equivalent | |
| K993184 | R1000 SERIES INSULIN PUMP | LZG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
Showing 25 of 28| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0136-2015 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. | Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen. | Class II | Terminated | |
| Z-0993-2013 | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. | Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected. | Class I | Terminated | |
| Z-0836-2013 | Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin. | Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that is displayed on the pump display. | Class III | Terminated | |
| Z-0137-2015 | Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. | Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability. | Class II | Terminated | |
| Z-0005-2013 | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. | Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad from the pump. | Class II | Terminated | |
| Z-1376-2012 | OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. | There is an error in the pump software where the OneTouch(R) Ping(R) insulin pump did not allow the user to save changes to the time and date on the pump if those changes were made on February 29, 2012 (Leap Day). Users who did not attempt to change the time or date on their pump on February 29, 2012 are not affected by this issue. | Terminated | ||
| Z-1034-2015 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. | Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011. | Class II | Terminated | |
| Z-3017-2011 | Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion. | Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery. | Terminated | ||
| Z-1678-2011 | 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion | Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking. | Terminated | ||
| Z-2397-2010 | Animas IR 1250 (1200 plus) Intended use:deliver insulin therapy | sensor could be damaged | Terminated | ||
| Z-2396-2010 | Animas IR 1200 Intended use:deliver insulin therapy | sensor could be damaged | Terminated | ||
| Z-2395-2010 | Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy | sensor could be damaged | Terminated | ||
| Z-2394-2010 | One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy | sensor could be damaged | Terminated | ||
| Z-1560-2010 | One Touch Ping Insulin Pump using ezManager Max diabetes management software | Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software. | Terminated | ||
| Z-0481-2010 | Animas ezManager Max Diabetes Management System version 2.0.9 | Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect. | Terminated | ||
| Z-0955-2009 | Meter Remote for OneTouch Ping Glucose Management System | incorrect dosing recommendation | Terminated | ||
| Z-0294-2009 | Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets. | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. | Terminated | ||
| Z-0293-2009 | Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets. | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. | Terminated | ||
| Z-0292-2009 | Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood glucose targets. | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. | Terminated | ||
| Z-0291-2009 | Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets. | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. | Terminated | ||
| Z-0283-2009 | One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level. | display old, inaccurate values for bolus amount delivered and amount of planned bolus totals | Terminated | ||
| Z-0290-2009 | Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets. | Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia. | Terminated | ||
| Z-0309-06 | Isulin Pump. Model IR1250 | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. | Terminated | ||
| Z-0308-06 | Isulin Pump. Model IR1200 | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. | Terminated | ||
| Z-0307-06 | Isulin Pump. Model IR1000 | Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain