FDA Adverse Event
Malfunction
Summary report: N
OT VERIO PRO METER
MDR report key: 3181156
·
Received June 21, 2013
Report
- Report Number
- 3008382007-2013-17935
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- June 11, 2013
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Removal / Correction Number
- 2013-IE-017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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
ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR 4. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283286 | OT VERIO PRO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3434186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |