FDA Adverse Event
Malfunction
Summary report: N
GLUCOSE MONITORING SYS/KIT
MDR report key: 2387033
·
Received December 22, 2011
Report
- Report Number
- 3008382007-2011-01149
- Event Type
- Malfunction
- Date Received
- December 22, 2011
- Report Date
- November 28, 2011
- Manufacturer
- LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE 510 (K) IS K093745.
Description of Event or Problem · 1
ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THERE WAS 1 VIAL OF TEST STRIPS MISSING FROM THE TEST STRIP BOX. THE REPORTER WAS UANBLE TO PROVIDE THE LOT NUMBER OF THE TEST STRIP BOX. THE REPORTED ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WERE NO ALLEGATIONS OF HARM OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |