FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1894831
·
Received November 5, 2010
Report
- Report Number
- 2531779-2010-02161
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS NOT RETURNED TO ANIMAS FOR EVALUATION. THE ANIMAS RN NOTED THAT THE PT WAS STILL USING THE PUMP.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO BUTTON PRESSES. THE PT ALSO CLAIMED THAT THE BUTTONS WOULD SOMETIMES GET STUCK. THE PT DENIED THAT THE PUMP WAS EXPOSED TO WATER. SHE ALSO CLAIMED THAT THE KEYPAD WAS INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | NONE | LZG | ANIMAS CORP. | IR 1250 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |