FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 3873498
·
Received June 14, 2014
Report
- Report Number
- 2939301-2014-14480
- Event Type
- Malfunction
- Date Received
- June 14, 2014
- Report Date
- June 11, 2014
- 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
- IN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER CONTACTED LIFESCAN USA ON (B)(6) 2014 ALLEGING THAT THE CONTROL SOLUTION RESULTS WERE ABOVE THE EXPECTED CONTROL SOLUTION RANGE. THE RESULT OBTAINED ON THE SUBJECT METER WAS "378MG/DL" AND THE ACCEPTABLE RANGE FOR THE CONTROL SOLUTION IS "102-138MG/DL". THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351723 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3441223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |