FDA Adverse Event
Malfunction
Summary report: N
OT VERIO TEST STRIPS
MDR report key: 2387016
·
Received December 22, 2011
Report
- Report Number
- 3008382007-2011-01147
- Event Type
- Malfunction
- Date Received
- December 22, 2011
- Report Date
- December 1, 2011
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE 510 (K) IS K093745.DEVICE EVALUATION=LIFESCAN RECEIVED THE TEST STRIPS INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2011. INVESTIGATION CONFIRMED THE ALLEGED ISSUE.
Description of Event or Problem · 1
ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE TEST STRIPS WERE STICKY. THE REPORTED ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WERE NO ALLEGATIONS OF HARM OF INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT VERIO TEST STRIPS | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL | 3184518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |