FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 2924347
·
Received January 22, 2013
Report
- Report Number
- 3008382007-2013-01196
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- December 28, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K110637
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS WITH RESULTS OF "332, 210, 250, 260 AND 500MG/DL". THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS OUT OF RANGE. 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 |
|---|---|---|---|---|---|---|---|
| 30819 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3319549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |