FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1800369
·
Received September 28, 2007
Report
- Report Number
- 2954323-2007-18276
- Event Type
- Malfunction
- Date Received
- September 28, 2007
- Date of Event
- August 31, 2007
- Report Date
- September 28, 2007
- Manufacturer
- ABBOTT DIABETES CARE LIMITED UK
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER'S METER AND TEST STRIPS HAVE BEEN RETURNED AND AN INVESTIGATION HAS DETERMINED THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THEY OBTAINED IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS OF 1.1 MMOL/L AND 15.7 MMOL/L WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTING EACH READING AGAINST THE AVERAGE ON A PARKES ERROR GRID, THE RESULTS FALL IN THE "B" AND "C" ZONES. THE "C" ZONE RESULT SHOWS THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION XTRA/OPTIUM | BLOOD GLUCOSE METER | NBW | ABBOTT DIABETES CARE LIMITED UK | NA | 42199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |