Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1560-2010

One Touch Ping Insulin Pump using ezManager Max diabetes management software

Animas Corp. / initiated 2009-12-18 / Terminated / root cause: 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.