FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1921872
·
Received December 7, 2010
Report
- Report Number
- 2531779-2010-02755
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Report Date
- November 11, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE LAY-USER/PATIENT ALLEGED THAT THE BUTTONS ON THE KEYPAD (UP AND DOWN BUTTONS) DO NOT RESPOND. THERE WAS PRODUCT MISUSE. THE KEYPAD DID NOT APPEAR TO BE PEELED OR TORN. FURTHERMORE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |