FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA / OPTIUM
MDR report key: 1041223
·
Received May 8, 2008
Report
- Report Number
- 2954323-2008-01754
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 10, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER RETURNED METER. THE COMPLAINT WAS NOT CONFIRMED, AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN SPECIFICATION, THE STANDARD DEVIATION WAS WITHIN SPECIFICATION, AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.
Description of Event or Problem · 1
A CUSTOMER REPORTED THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION EXTRA METER. THE CUSTOMER REPORTED THEY OBTAINED READINGS OF 27.8 MMOL/L AND 8.5 MMOL/L WITHIN A 10 MINUTE TIMESCALE. ALL TESTS WERE PERFORMED ON THE FINGER. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL IN THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA / OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NI | 80173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |