FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2180907
·
Received July 27, 2011
Report
- Report Number
- 2531779-2011-05354
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Report Date
- May 5, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(6) 2011. (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION REVEALED A DISLODGED DISPLAY SCREEN AND PARTIALLY DISLODGED FORCE SENSOR PINS. A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS NOT DUPLICATED DURING TESTING. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.
Description of Event or Problem · 1
EVALUATION REVEALED PARTIALLY DISLODGED FORCE SENSOR PINS. 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 | 66 YR |