FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1041230
·
Received May 8, 2008
Report
- Report Number
- 2954323-2008-01761
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 11, 2008
- Report Date
- May 8, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
A CUSTOMER REPORTED THEY OBTAINED HIGH READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. THE CUSTOMER REPORTED THEY OBTAINED A READING OF 140 MG/DL COMPARED TO 75 MG/DL WITH A LABORATORY METER WITHIN A 10 MINUTE TIMESCALE. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL IN THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FREEDOM | BLOOD GLUCOSE METER | LFR | ABBOTT DIABETES CARE INC, USA | NI | 0774902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |