One Touch Ping Insulin Pump using ezManager Max diabetes management software
Animas Corporation began a recall of One Touch Ping Insulin Pump using ezManager Max diabetes management software on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-1560-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Animas Corp.
- Product
- One Touch Ping Insulin Pump using ezManager Max diabetes management software
- Product code
- LZG Pump, Infusion, Insulin
- Reason for recall
- 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.
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users.
- Quantity in commerce
- 21 pumps
- Distribution
- The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA
- Product codes and lots
- Pump serial numbers: 00-72187-15, 00-72194-15, 01-72188-15, 02-72196-15, 04-70673-15, 05-72199-15, 11-70768-15, 18-67503-15, 23-69304-15, 25-66538-15, 30-69170-15, 40-69613-15, 67-69696-15, 75-72201-15, 76-72202-15, 89-71176-15, 90-71177-15, 96-70468-15, 97-72191-15, 98-72192-15, and 99-72193-15.
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