FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1122794
·
Received August 13, 2008
Report
- Report Number
- 2954323-2008-02397
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 14, 2008
- Report Date
- August 13, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION, AND A FINAL REPORT WILL BE SUBMITTED IF RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
A CUSTOMER REPORTED OBTAINING IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XCEED METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 28 MG/DL AND 271 MG/DL WITHIN A 10-MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID, THE RESULTS FELL IN THE 'C' ZONE, RESULTS IN THIS ZONE ARE DEEMED CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OF MISTREATMENT ASSOCIATED WITH THIS CASE.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |