FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1020836
·
Received May 30, 2007
Report
- Report Number
- 2954323-2007-09078
- Event Type
- Malfunction
- Date Received
- May 30, 2007
- Date of Event
- February 14, 2007
- Report Date
- May 30, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE METER HAS BEEN CONFIRMED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE FA16MAY2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THEY OBSERVED AN ERROR 4 MESSAGE ON THEIR FREESTYLE FLASH METER. THE CUSTOMER'S METER WAS RETURNED FOR INVESTIGATION AND TESTING CONFIRMED THE METER TO EXHIBIT 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. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |