FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA /OPTIUM
MDR report key: 1063010
·
Received June 18, 2008
Report
- Report Number
- 2954323-2008-02127
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 21, 2008
- Report Date
- June 18, 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 PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 22 MG/DL AND 105 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 | PRECISION XTRA /OPTIUM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |