FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1063011
·
Received June 18, 2008
Report
- Report Number
- 2954323-2008-02128
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 21, 2008
- Report Date
- June 18, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING INACCURATE BLOOD GLUCOSE TESTS ON THEIR FREESTYLE FREEDOM METER. CUSTOMER RECEIVED READINGS OF 193 MG/DL COMPARED TO A LAB READING OF 83 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE 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 | BLODO GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0801838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |