FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1921822
·
Received December 7, 2010
Report
- Report Number
- 2531779-2010-02757
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Report Date
- November 8, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. THE PT DECLINED TO RETURN THE PRODUCT TO ANIMAS FOR EVALUATION.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PT CLAIMED THAT THE PUMP WAS INCREASING UNRESPONSIVE TO OK BUTTON PRESSES. THE PT CLAIMED THAT THE KEYPAD WAS NOT PEELING OR DAMAGED. THE PT DENIED THAT THE DEVICE WAS EXPOSED TO WATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | IR 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |