FDA Adverse Event
Malfunction
Summary report: N
OT VERIO METER
MDR report key: 2193892
·
Received August 5, 2011
Report
- Report Number
- 3008382007-2011-00161
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Report Date
- July 10, 2011
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE 510 (K) IS K093745. 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 REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING AN "ERROR 4" ISSUE WITH THE SUBJECT METER. THE REPORTED ISSUE WAS NOT RESOLVED WITH CUSTOMER SERVICE TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3067980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |