FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1012098
·
Received May 14, 2007
Report
- Report Number
- 2954323-2007-07864
- Event Type
- Malfunction
- Date Received
- May 14, 2007
- Date of Event
- April 16, 2007
- Report Date
- May 15, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC., USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 154 MG/DL AND 32 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE ARM. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" 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 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC., USA | NA | 0632230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |