FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2081987
·
Received May 9, 2011
Report
- Report Number
- 2531779-2011-03233
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/2011 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION CONFIRMED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. IT WAS OBSERVED THAT THE UP ARROW KEY CONTACT IS MISALIGNED. THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL BUTTON KEY CONTACTS.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE KEYPAD BUTTONS HAVE BEEN INTERMITTENTLY UNRESPONSIVE FOR THE PAST (B)(6). HE NOTED THAT THE KEYPAD BUTTONS FEEL NORMAL, SPRING BACK WHEN PRESSED, AND THAT THEY DO NOT STICK. THE PATIENT CONFIRMED THAT THE KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO MOISTURE; AND STATED THAT HE WEARS THE PUMP ON HIS WAIST.
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 | 70 YR |