FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2092021
·
Received May 18, 2011
Report
- Report Number
- 2531779-2011-03508
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 19, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT ALL BUTTONS OTHER THAN THE AUDIO BOLUS BUTTON INTERMITTENTLY ACTIVATED PUMP FUNCTIONS WHEN PRESSED. THE AUDIO BOLUS BUTTON FUNCTIONED PROPERLY. CONTAMINATION WAS OBSERVED UNDER ALL KEY CONTACTS EXCEPT THE AUDIO BOLUS BUTTON CONTACT. UNRELATED TO THE COMPLAINT AN UNIDENTIFIED DISPLAY FAILURE WAS OBSERVED.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE CONTRAST BUTTON WAS STICKING AND ALL THE WRITING ON THE BUTTONS WORE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANM 2020 INSULIN INFUSION PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |