FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1053054
·
Received May 30, 2008
Report
- Report Number
- 2954323-2007-08825
- Event Type
- Malfunction
- Date Received
- May 30, 2008
- Date of Event
- April 25, 2007
- Report Date
- May 24, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE METER HAS BEEN CONFIMRED TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED.
Description of Event or Problem · 1
CUSTOMER REPORTED BELIEVING HER LOCKED FREESTYLE METER WAS NOT READING ACCURATELY BECAUSE SHE WAS FEELING "LOW" BUT THE METER WAS READING "HIGHER" THAN WHAT SHE EXPECTED. SHE REPORTED SYMPTOMS INCLUDING: " FEELING NERVOUS, DIZZY AND SHAKY". SHE ATE PEANUT BUTTER AND GRAHAM CRACKERS TO AMELIORATE HER SYMPTOMS. THE METER WAS RETURNED AND AN INVESTIGATION DETERMINED IT HAD EXHIBITED THE MEMORY OVERWRITE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC | NI | 0701816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |