FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1873114
·
Received October 15, 2010
Report
- Report Number
- 2531779-2010-01702
- Event Type
- Injury
- Date Received
- October 15, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL 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 PT IS REPORTEDLY PRESSING THE UP, DOWN, AND OK BUTTONS MULTIPLE TIMES FOR THE PUMP TO RESPOND AND THE BUTTONS DO NOT SPRING BACK AS NORMAL. THE PUMP REPORTEDLY HAS NOT BEEN EXPOSED TO MOISTURE.
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 |