FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE LITE
MDR report key: 1060723
·
Received June 11, 2008
Report
- Report Number
- 2954323-2008-02081
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- May 17, 2008
- Report Date
- June 11, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 ERRATIC READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 455 MG/DL, 259 MG/DL AND 139 MG/DL WERE PLOTTED ON A PARKES ERROR GRID. THE RESULTS 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 LITE | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0807103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |