FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA /OPTIUM
MDR report key: 1161458
·
Received September 12, 2008
Report
- Report Number
- 2954323-2008-02544
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 14, 2008
- Report Date
- September 12, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NO INFORMATION
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 IMPRECISE READINGS ON THEIR BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 1.3 MMOL/L AND 17.8 MMOL/L 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 | PRECISION XTRA /OPTIUM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC, USA | NI | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |