FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2142374
·
Received June 28, 2011
Report
- Report Number
- 2531779-2011-04528
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- April 13, 2011
- Report Date
- May 6, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION COMPLETED ON 06/01/2011. (B)(6). RECALL 2531779-03/24/2010-003-R. DURING EVALUATION THE FORCE SENSOR ASSEMBLY WAS FOUND TO BE DAMAGED. UNRELATED TO THE COMPLAINT, THE PUMP'S BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE BATTERY CAP WAS FOUND TO BE STRIPPED, AND WOULD NOT MAINTAIN POWER. FURTHER TESTING WAS COMPLETED WITH A TEST BATTERY CAP.
Description of Event or Problem · 1
PUMP IS RETURNED FOR MULTIPLE LOSS OF PRIME ALARMS. EVALUATION REVEALED A DAMAGED FORCE SENSOR ASSEMBLY. 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 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |