FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE FLASH
MDR report key: 1790359
·
Received August 2, 2007
Report
- Report Number
- 2954323-2007-13941
- Event Type
- Malfunction
- Date Received
- August 2, 2007
- Date of Event
- July 3, 2007
- Report Date
- August 2, 2007
- 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
(B)(4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE. CUSTOMERS AND RETAILERS HAVE BEEN INFORMED THROUGH THE ADC FA16MAY2006 LETTER.
Description of Event or Problem · 1
CUSTOMER REPORTED RECEIVING AN ERROR MESSAGE ON THEIR LOCKED FREESTYLE FLASH METER. DURING THE COURSE OF TROUBLESHOOTING WITH ADC CUSTOMER SERVICE, IT WAS DISCOVERED THAT THE UNIT OF MEASURE COULD BE CHANGED. THE METER IS EXHIBITING SIGNS OF THE MEMORY OVERWRITE MALFUNCTION. 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 FLASH | BLOOD GLUCOSE MONITORING SYSTEM | LFR | ABBOTT DIABETES CARE INC, USA | NA | 0627320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |