FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE
MDR report key: 1079292
·
Received July 18, 2008
Report
- Report Number
- 2954323-2008-02283
- Event Type
- Malfunction
- Date Received
- July 18, 2008
- Date of Event
- June 24, 2008
- Report Date
- July 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 ERRATIC READINGS ON THEIR FREESTYLE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF (217, 113, 262, 378, 362, 479 AND 501 MG/DL) WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. 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 | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0709201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |