FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 831352
·
Received March 13, 2007
Report
- Report Number
- 2954323-2007-02779
- Event Type
- Malfunction
- Date Received
- March 13, 2007
- Date of Event
- February 13, 2007
- Report Date
- March 13, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR CHANGED FROM MMOL/L TO MG/DL. THE CUSTOMER ALSO HAD OBSERVED AN ERROR AND THE BATTERY AND BOOK ICONS ON THEIR DISPLAY. THIS METER HAS VERY LIKELY EXHIBITED THE MEMORY OVERWRITE MALFUNCTION. 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 | 0620817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |