FDA Adverse Event
Malfunction
Summary report: N
OT VERIO IQ METER
MDR report key: 4873291
·
Received June 27, 2015
Report
- Report Number
- 2939301-2015-26819
- Event Type
- Malfunction
- Date Received
- June 27, 2015
- Report Date
- June 19, 2015
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP # 1, THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. WHEN TEST STRIPS WERE TESTED WITH CONTROL SOLUTION, AN ERROR 4 WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. 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) 2015, 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 |
|---|---|---|---|---|---|---|---|
| 416815 | OT VERIO IQ METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3580906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |