FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA /OPTIUM
MDR report key: 1122836
·
Received August 14, 2008
Report
- Report Number
- 2954323-2008-02405
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 22, 2008
- Report Date
- August 14, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC., USA
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE METER HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 440 MG/DL AND 86 MG/DL WERE PLOTTED ON A PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONES 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 | PRECISION XTRA /OPTIUM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC., USA | NA | 43023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |