FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA
MDR report key: 1162164
·
Received September 15, 2008
Report
- Report Number
- 2954323-2008-02553
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 19, 2008
- Report Date
- September 15, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING AN INACCURATELY HIGH READING ON HER PRECISION XTRA METER AS COMPARED TO A LABORATORY METER. CUSTOMER RECEIVED A READING OF 246 MG/DL, COMPARED TO A LAB READING OF 81 MG/DL, WITHIN A 10-MINUTE TIMEFRAME. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "D" 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 | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC, USA | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |