FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2071941
·
Received April 28, 2011
Report
- Report Number
- 2531779-2011-02961
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 4, 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 CONTAMINATION UNDER KEYPAD BUTTON CONTACTS AND THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED. UNRELATED TO THE ISSUE, THE PUMP BATTERY COMPARTMENT WAS CRACKED WHICH IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY AS IT IS OBVIOUS AND DETECTABLE AND THE OWNER'S BOOKLET INSTRUCTS THE USER TO CHECK FOR CHIPS, CRACKS AND LEAKS.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THAT THE OK BUTTON WAS STICKING.
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 |