Recall Z-1034-2015 ยท OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Animas Corporation
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.
| Date | Jan 30, 2015 (initiated Sep 6, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| Action | The field action was initiated on 8/29/2011 and comprised communication to patients and distributors using email, letters and verbal communication. In addition, notifications were sent to those Health Care Professionals who had patients that were affected by this field action. Health Authorities were notified in those countries where the pump had been distributed (France, Germany, Sweden and United Kingdom) or was in the hands of patients. Replacement product was provided to distributors and end users who were identified as having affected product. |
| Quantity | 1235 |
| Distribution | No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.