FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2181082
·
Received July 27, 2011
Report
- Report Number
- 2531779-2011-05358
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Report Date
- May 9, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(4) 2011. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION AND THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE PHYSICALLY DAMAGED.
Description of Event or Problem · 1
PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS BEING MADE BASED ON THE EVALUATION RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 1250 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |