FDA Adverse Event
Malfunction
Summary report: N
OT VERIO METER
MDR report key: 3000827
·
Received March 13, 2013
Report
- Report Number
- 3008382007-2013-04703
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Report Date
- February 12, 2013
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- PMA / PMN Number
- K093745
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG, HOWEVER, NO MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTING. PA WAS UNABLE TO REPRODUCE THE COMPLAINT.THE TEST STRIPS HAVE ALSO BEEN RETURNED, HOWEVER, TESTING WAS NOT PERFORMED SINCE THE STRIPS WERE EXPIRED AT THE TIME OF THE COMPLIAINT.IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.
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 |
|---|---|---|---|---|---|---|---|
| 105648 | OT VERIO METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3196947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |