FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1163311
·
Received September 9, 2008
Report
- Report Number
- 2531779-2008-00564
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 6, 2008
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION HAS NOT YET BEEN COMPLETED.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED HYPOGLYCEMIA AND REPORTED THAT THE PUMP DELIVERED AN UNPROGRAMMED AMOUNT OF INSULIN. NO MEDICAL TREATMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |