FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2924834
·
Received January 22, 2013
Report
- Report Number
- 2531779-2013-00970
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- December 26, 2012
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS. THE OK BUTTON SYMBOL WAS FOUND TO BE WORN BUT THE KEYPAD WAS FOUND TO BE INTACT. THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING NORMALLY TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED TO ANIMAS. INVESTIGATION REVEALED CONTAMINATION UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28885 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |