FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2091643
·
Received May 17, 2011
Report
- Report Number
- 2531779-2011-03465
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Report Date
- April 25, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 05/13/2011. ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.
Description of Event or Problem · 1
PATIENT REPORTS THAT UP ARROW BUTTON HAS BEEN INTERMITTENTLY RESPONDING FOR TWO WEEKS AND TODAY IS COMPLETELY UNRESPONSIVE. PATIENT DOES NOT CLEAN THE PUMP. PATIENT WEARS PUMP ATTACHED TO BELT.
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 | 39 YR |