FDA Adverse Event
Malfunction
Summary report: N
PRECISION XTRA/OPTIUM
MDR report key: 1190672
·
Received October 6, 2008
Report
- Report Number
- 2954323-2008-02682
- Event Type
- Malfunction
- Date Received
- October 6, 2008
- Date of Event
- September 24, 2008
- Report Date
- October 6, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC.
- 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 CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR BLOOD GLUCOSE MONITOR. CUSTOMER RECEIVED READINGS OF 387 MG/DL COMPARED TO A LAB READING OF 83 MG/DL WITHIN 10 MINUTES. 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/OPTIUM | BLOOD GLUCOSE MONITORING SYSTEM | NBW | ABBOTT DIABETES CARE INC. | NA | 43068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |