FDA Adverse Event
Malfunction
Summary report: N
OT VERIO2 METER
MDR report key: 4870255
·
Received June 26, 2015
Report
- Report Number
- 2939301-2015-26435
- Event Type
- Malfunction
- Date Received
- June 26, 2015
- Report Date
- June 3, 2015
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K131363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE HIGH RESULTS ON THE SUBJECT METER COMPARED TO ANOTHER METER. NO RESULTS WERE PROVIDED FOR EITHER METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE UNKNOWN RESULTS MAY NOT MEET LIFESCAN¿S ACCURACY CRITERIA AND THE ALLEGED INACCURACY 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 |
|---|---|---|---|---|---|---|---|
| 416578 | OT VERIO2 METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3771668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |