FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 2171498
·
Received July 21, 2011
Report
- Report Number
- 3008382007-2011-00052
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIOPRO METER HAD SEGMENTS MISSING FROM THE CHARACTERS ON THE DISPLAY. THE ISSUE WAS NOT RESOLVED. THE PATIENT SUFFERED NO INJURY DUE TO THIS ISSUE. THE METER WAS REPLACED.
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 | 18 YR |