Device product
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.
Z-1034-2015
Product summary
- Event
- Event 69299
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1235
- Official record key
device-enforcement:Z-1034-2015
Official wording
Reason: 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.
Code information: Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63
Distribution pattern: No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
Derived failure modes
-
Unknown
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.