FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1782098
·
Received June 27, 2007
Report
- Report Number
- 2954323-2007-11406
- Event Type
- Malfunction
- Date Received
- June 27, 2007
- Date of Event
- May 28, 2007
- Report Date
- June 27, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
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 ADC FA16MAY2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED AN ISSUE WITH THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR. UPON PRODUCT INVESTIGATION, IT WAS DISCOVERED THE METER 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 | 0603712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |