FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1052064
·
Received May 20, 2008
Report
- Report Number
- 2954323-2008-01887
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- April 21, 2008
- Report Date
- May 20, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC., USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
A CUSTOMER REPORTED RECEIVING A READING OF 5.8 MMOL/L ON HER FREESTYLE FLASH BLOOD GLUCOSE METER AND COMPARING TO A LABORATORY RESULT OF 3.5 MMOL/L. THE TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE. THE "C" ZONE RESULT SHOWS 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 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC., USA | NA | 0800803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |