FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1821763
·
Received August 25, 2010
Report
- Report Number
- 2531779-2010-01088
- Event Type
- Malfunction
- Date Received
- August 25, 2010
- Date of Event
- July 27, 2010
- Report Date
- July 27, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECIFICATIONS. A CRACK IN THE BATTERY COMPARTMENT WAS OBSERVED AND THERE WAS EVIDENCE OF CORROSION IN THE BATTERY COMPARTMENT AND ON THE BATTERY CAP. THE PUMP WAS EXERCISED WITH NO EVIDENCE OF OVERHEATING OBSERVED. ELECTRICAL CURRENT DRAWS WERE CONDUCTED, WHICH WERE WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP FELT HOT TO THE TOUCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | IR 1200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |