FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2890029
·
Received December 28, 2012
Report
- Report Number
- 3008382007-2012-09114
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Report Date
- December 7, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K082590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP # 1 (02/14/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.
Description of Event or Problem · 1
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING PC WAS APPEARING ON THE METER DISPLAY WHEN POWERED ON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |