FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 928998
·
Received April 5, 2007
Report
- Report Number
- 2954323-2007-04181
- Event Type
- Malfunction
- Date Received
- April 5, 2007
- Date of Event
- March 6, 2007
- Report Date
- April 5, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC., USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT IS CONFIRMED. PERFORMED INVESTIGATION. METER IS UNLOCKED TO MG/DL. READINGS WITH A 26 CAL CODE WERE FOUND IN GLUCOSE LOG. ERRORS 015, 0204, 0300, 0800 AND 0806 WERE FOUND IN ERROR LOG. CALIBRATION PARAMETERS WERE WITHIN SPECIFICATION. MEMORY OVERWRITE WAS OBSERVED. METER IS INOPERABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.
Description of Event or Problem · 1
CUSTOMER REPORTED THEIR FREESTYLE FLASH (MINI) METER WAS READING HIGH BECAUSE THE UNIT OF MEASUREMENT 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 | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |