FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1874161
·
Received October 15, 2010
Report
- Report Number
- 2531779-2010-01693
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 21, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY DIFFICULT TO PUSH. EVAL ALSO REVEALED THAT THE BUTTON CONTACTS WERE CONTAMINATED.
Description of Event or Problem · 1
THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT RESPONDING TO PRESSING OF THE KEYPAD BUTTONS. THE PT ALSO CLAIMED THAT THE BUTTONS DID NOT FEEL NORMAL AND WERE HARD TO PRESS. THE PT DENIED THAT THE KEYPAD WAS PEELING OR DAMAGED.
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 | 46 YR |