FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1008851
·
Received April 27, 2007
Report
- Report Number
- 2954323-2007-06124
- Event Type
- Malfunction
- Date Received
- April 27, 2007
- Date of Event
- March 28, 2007
- Report Date
- April 27, 2007
- Manufacturer
- ABBOTT DIABETES CARE, INC., USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED FOR EVALUATION. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE LETTER.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE AND ADD'L ICONS ON HER UNLOCKED FREESTYLE FLASH METER. THESE MESSAGES ARE AN INDICATION THE DEVICE MAY HAVE EXHIBITED THE MEMORY OVERWRITE MALFUNCTION. SHE ALSO REPORTED THE UNIT OF MEASURE HAD CHANGED FROM MMOL/L TO MG/DL. 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 | NI | 0607626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |