FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1060713
·
Received June 10, 2008
Report
- Report Number
- 2954323-2008-02074
- Event Type
- Malfunction
- Date Received
- June 10, 2008
- Date of Event
- May 14, 2008
- Report Date
- June 10, 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
RETAIN SAMPLE TESTING ON THE COMPLAINANT STRIP LOT HAS CONFIRMED A MANUFACTURING ISSUE RESULTING IN ERROR 3 MESSAGES WHEN THESE STRIPS ARE USED WITH FREESTYLE FREEDOM METERS. TESTING CONCLUDED THAT NOT ALL STRIPS IN AFFECTED VIALS ARE IMPACTED. THIS ISSUE IS ASSOCIATED WITH FIELD CORRECTION 2954323 REPORTED TO FACILITY.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING AN ERROR 3 MESSAGE WHEN A TEST STRIP WAS INSERTED IN THEIR FREESTYLE FREEDOM METER. 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 | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC. USA | NI | 0703118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |