FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 2970901
·
Received February 21, 2013
Report
- Report Number
- 3008382007-2013-03356
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Report Date
- January 25, 2013
- 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): HOWEVER, THE PRIMARY ISSUE WAS WITH THE LANCET DEVICE. SINCE THE LANCING DEVICE WAS NOT AVAILABLE, TESTING COULD NOT BE PERFORMED ON THE LANCING DEVICE. 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 HE RECEIVED A METER KIT THAT WAS NOT SEALED WHEN HE RECEIVED IT AND NOTICED THAT A LANCET WAS IN THE LANCING DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 75692 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |