FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 2072208
·
Received April 28, 2011
Report
- Report Number
- 2531779-2011-02974
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 31, 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. ALL KEYPAD BUTTONS WERE INTERMITTENTLY ACTIVATING PUMP FUNCTIONS WHEN PRESSED.
Description of Event or Problem · 1
THE DISTRIBUTOR STATED THAT THE PATIENT NEEDED TO PRESS THE BUTTON SEVERAL TIMES TO ACTIVATE DESIRED PUMP FUNCTIONS.
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 |