FDA Adverse Event
Malfunction
Summary report: N
MEDISENSE OPTIUM
MDR report key: 1052443
·
Received May 21, 2008
Report
- Report Number
- 2954323-2008-01901
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Report Date
- May 21, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
A CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR MEDISENSE BLOOD GLUCOSE METER WITHIN 10 MINUTES. IT IS UNK WHEN THE ISSUE HAPPENED. RESULTS OF 500 MG/DL, 261 MG/DL AND 92 MG/DL WERE PLOTTED ON A PARKES ERROR GRID AND FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDISENSE OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | 42952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |