FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 2883753
·
Received December 21, 2012
Report
- Report Number
- 3008382007-2012-08798
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Report Date
- December 14, 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
Additional Manufacturer Narrative · 1
LOT # OF THE TEST STRIPS WERE NOT PROVIDED.
Description of Event or Problem · 1
ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (B)(4), THAT THERE WAS SOMETHING WRONG WITH THE METER. CUSTOMER SERVICE HAD THE REPORTER POWER THE METER ON AND RAN A QUALITY CONTROL TEST AND METER PASSED TESTING. SINCE IT IS UNKNOWN WHAT THE ISSUE IS, CUSTOMER SERVICE REQUESTED THE PATIENT TO CONTACT LFS. PRODUCTS SEEMS TO BE WORKING AND IS NOT BEING REPLACED AT THIS TIME.
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 | 57 YR |