FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 2850312
·
Received November 29, 2012
Report
- Report Number
- 3008382007-2012-06887
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Report Date
- November 13, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE PHARMACIST CALLED LFS ON BEHALF OF THE PATIENT AND ASKED FOR A REPLACEMENT VERIO PRO METER. THE PHARMACIST DID NOT HAVE THE SERIAL NUMBER OR LOT # OF THE TEST STRIPS AVAILABLE TO TROUBLESHOOT. IT IS UNKNOWN WHAT THE ISSUE IS WITH THE METER. THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THERE WAS A PROBLEM WITH THE PATIENT¿S METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO PRO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |