FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 860650
·
Received March 22, 2007
Report
- Report Number
- 2954323-2007-03257
- Event Type
- Malfunction
- Date Received
- March 22, 2007
- Date of Event
- February 20, 2007
- Report Date
- March 22, 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. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA 16 MAY, 2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE UNIT OF MEASUREMENT SETTING OF THEIR FREESTYLE BLOOD GLUCOSE MONITOR CHANGED FROM MMOL/L TO MG/DL, AND ALSO THEY WERE RECEIVING AN ERROR 4 MESSAGE WHEN INSERTING STRIPS. 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 | 0625529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |