FDA Adverse Event
Malfunction
Summary report: N
OT PING METER
MDR report key: 2993737
·
Received March 7, 2013
Report
- Report Number
- 3008382007-2013-04400
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- February 7, 2013
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE METER FAILED TESTING. THE METER¿S BATTERY WAS FOUND TO HAVE A LOW VOLTAGE. AFTER PA REPLACED THE BATTERY, THE METER FUNCTIONED 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)(4) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING DOES NOT TURN 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 |
|---|---|---|---|---|---|---|---|
| 96810 | OT PING METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3319580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |