FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1060716
·
Received June 10, 2008
Report
- Report Number
- 2954323-2008-02077
- Event Type
- Malfunction
- Date Received
- June 10, 2008
- Date of Event
- May 15, 2008
- Report Date
- June 10, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 277 MG/DL, 50 MG/DL, AND 171 MG/DL WERE PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 FREEDOM | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0805915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |