FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2042883
·
Received March 30, 2011
Report
- Report Number
- 2531779-2011-02063
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. IT WAS NOTED THAT ALL BUTTON SYMBOLS WERE WORN. THE DOWN ARROW KEYPAD BUTTON WAS UNRESPONSIVE DURING TESTING. IT WAS OBSERVED THAT ALL KEYPAD BUTTONS SPRING BACK AS EXPECTED WHEN PRESSED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER THE DOWN ARROW KEY CONTACT.
Description of Event or Problem · 1
A DISTRIBUTOR REPORTED THAT THE KEYPAD BUTTONS ARE UNRESPONSIVE.
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 |