FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FREEDOM
MDR report key: 1060728
·
Received June 11, 2008
Report
- Report Number
- 2954323-2008-02084
- 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
- NOT APPLICABLE
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 REPORTED TO THE DISTRICT OFFICE IN 2008.
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 | NA | 0715129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |