FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 2761097
·
Received September 26, 2012
Report
- Report Number
- 3008382007-2012-04571
- Event Type
- Malfunction
- Date Received
- September 26, 2012
- Report Date
- August 31, 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
- US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HE HAD RECEIVED A ONETOUCH VERIO IQ METER SYSTEM FROM HIS DOCTOR, BUT IT WAS MISSING THE MINI USB AND AC ADAPTER. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DECLINED REPLACEMENT PRODUCTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THE PATIENT ALLEGED THE METER SYSTEM WAS MISSING THE MINI USB AND AC ADAPTER. THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS, TREATMENT, OR BLOOD GLUCOSE VALUES SUGGESTIVE OF A SERIOUS INJURY.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |