FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1020837
·
Received May 30, 2007
Report
- Report Number
- 2954323-2007-09075
- Event Type
- Malfunction
- Date Received
- May 30, 2007
- Date of Event
- May 1, 2007
- Report Date
- May 30, 2007
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- LFR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT THE UNITS OF MEASUREMENT SETTING OF THEIR FREESTYLE FLASH METER CHANGED. THE CUSTOMER ALSO OBSERVED AN ERROR 4 MESSAGE DURING THE INSERTION OF A TEST STRIP. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER'S METER HAS BEEN RETURNED; INVESTIGATIONS ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREESTYLE FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |