FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1821122
·
Received August 28, 2010
Report
- Report Number
- 2531779-2010-01141
- Event Type
- Malfunction
- Date Received
- August 28, 2010
- Date of Event
- July 29, 2010
- Report Date
- July 29, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO REPORTED PT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THERE WAS VISIBLE MOISTURE INGRESS CAUSING CORROSION AROUND A BATTERY TERMINAL. THE PUMP WAS BOOTED AND EXERCISED WITH NO OVERHEATING OR POWER LOSS DUPLICATED. CURRENT DRAWS WERE CONDUCTED AND FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP BATTERY WAS 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 CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |