FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1894725
·
Received November 5, 2010
Report
- Report Number
- 2531779-2010-02104
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 7, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS AND THE EVAL REVEALED THAT THE KEYPAD APPEARED TO BE SWOLLEN. ALL KEYPAD BUTTONS WERE RESPONSIVE TO USER INPUTS. ALL KEYPAD BUTTONS CLICK AND SPRING BACK NORMALLY. THE KEYPAD WAS REMOVED AND THERE WAS EVIDENCE OF KEYPAD ADHESIVE FOUND UNDER ALL KEY CONTACTS. ADDITIONALLY, THE BOLUS BUTTON WAS DIFFICULT TO PUSH.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE BUTTONS WERE NOT RESPONDING ON THE KEYPAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |