FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1954341
·
Received December 13, 2010
Report
- Report Number
- 2531779-2010-02843
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Report Date
- October 4, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE BOLUS BUTTON WAS MISSING, ALL KEYPAD BUTTONS WERE INTERMITTENTLY RESPONSIVE TO USER INPUT DURING TESTING, AND CONTAMINATION WAS OBSERVED UNDER ALL THE KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE KEYPAD BUTTONS NOT RESPONDING WHEN PRESSED. IT WAS REPORTED THAT THE KEYPAD BUTTONS FEEL AND CLICK NORMALLY AND THAT THE KEYPAD IS INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
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 |