FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE MINI
MDR report key: 835492
·
Received February 16, 2007
Report
- Report Number
- 2954323-2007-01895
- Event Type
- Malfunction
- Date Received
- February 16, 2007
- Date of Event
- January 19, 2007
- Report Date
- February 16, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT THEY REC'D AN ERROR 4 MESSAGE WHEN INSERTING A STRIP INTO THEIR FREESTYLE METER. THEY ALSO REPORT SEEING A BATTERY ICON, A CODE CHANGE FROM 2 TO 18, AND THE UNIT OF MEASURE CHANGED FROM MMOL/L TO MG/DL. THIS IS INDICATIVE OF THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE MINI | BLOOD GLCUSOE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NI | 0623821 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |