FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1051627
·
Received May 19, 2008
Report
- Report Number
- 2954323-2008-01873
- Event Type
- Malfunction
- Date Received
- May 19, 2008
- Date of Event
- April 20, 2008
- Report Date
- May 19, 2008
- Manufacturer
- ABBOTT DIABETES CARE INC, USA
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER'S PRODUCT HAS BEEN RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING IMPRECISE SEQUENTIAL READINGS ON HER FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER OBTAINED READINGS OF 328 MG/DL, 41 MG/DL, 172 MG/DL, 276 MG/DL AND 274 MG/DL. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL INTO THE "C" ZONE SHOWING DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. ALL TESTS WERE PERFORMED ON THE FINGER. THERE WAS NO REPORT OF SERIOUS INJURY, DEATH OR PERMANENT IMPAIRMENT 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 | NI | 0804427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |