FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 2873290
·
Received December 13, 2012
Report
- Report Number
- 3008382007-2012-08194
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Report Date
- November 28, 2012
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K110637
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. THE PRODUCT(S) HAVE NOT YET BEEN EVALUATED; LFS WILL EVALUATE IT/THEM AND INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(4) 2012, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING SHE ONLY RECEIVED 5 TEST STRIPS AND 5 LANCETS IN STARTER KIT. 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. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3283980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |