FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1770464
·
Received June 12, 2007
Report
- Report Number
- 2954323-2007-10186
- Event Type
- Malfunction
- Date Received
- June 12, 2007
- Date of Event
- March 20, 2007
- Report Date
- June 12, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
(B) (4). 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
THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |