FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2043319
·
Received March 15, 2011
Report
- Report Number
- 2531779-2011-01570
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- December 1, 2010
- Report Date
- February 15, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE PATIENT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND OVER (B)(6), AND NOW THE BUTTONS DO NOT RESPOND AT ALL. SHE NOTED THAT SHE INTERMITTENTLY FEELS THE KEYPAD BUTTONS CLICK AND SPRING BACK WITH BUTTON PRESSES. THE PATIENT DENIED PHYSICAL DAMAGE TO THE RUBBER KEYPAD; DENIED EXPOSING THE PUMP TO WATER; STATED THAT SHE CLEANS THE PUMP WITH AN ALCOHOL PREP PAD; AND STATED THAT SHE WEARS THE PUMP ON HER WAIST WITH A CLIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR1200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR |