FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 2884322
·
Received December 22, 2012
Report
- Report Number
- 3008382007-2012-08909
- Event Type
- Malfunction
- Date Received
- December 22, 2012
- Report Date
- December 12, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING AN UNKNOWN ISSUE WITH NOT BEING ABLE TO "READ THE TEST STRIPS" WITH THE ONETOUCH METER VERIOPRO METER. THE PATIENT DID NOT HAVE THE TESTING SUPPLIES AT THE TIME OF TROUBLESHOOTING. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.
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 |