FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 4201645
·
Received October 27, 2014
Report
- Report Number
- 2939301-2014-28783
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Report Date
- October 19, 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
- WA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING TESTING. 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) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING ERROR 1. 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 |
|---|---|---|---|---|---|---|---|
| 681290 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3669210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |