FDA Adverse Event
Malfunction
Summary report: N
OT VERIO2 METER
MDR report key: 6799743
·
Received August 17, 2017
Report
- Report Number
- 3008382007-2017-22228
- Event Type
- Malfunction
- Date Received
- August 17, 2017
- Report Date
- August 2, 2017
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- UDI-DI
- 00353885008730
- PMA / PMN Number
- K131363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE ERRATIC RESULTS ON THE SUBJECT METER OF "534, 110, 347 AND 164 MG/DL", PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S PRECISION 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 |
|---|---|---|---|---|---|---|---|
| 581145 | OT VERIO2 METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 4094158 | 00353885008730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |