FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE
MDR report key: 1011219
·
Received May 11, 2007
Report
- Report Number
- 2954323-2007-07681
- Event Type
- Malfunction
- Date Received
- May 11, 2007
- Date of Event
- April 11, 2007
- Report Date
- May 11, 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
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL 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 3, WHEN A TEST STRIP WAS INSERTED AND ICONS ON THEIR METER, WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THE CUSTOMER ALSO REPORTED, FEELING POORLY FOR ABOUT 2 WEEKS ASSOCIATED WITH INCREASED THIRST AND CONFUSION. THERE WAS NO THIRD PARTY MEDICAL INTERVENTION NOTED; HOWEVER, THE CUSTOMER WAS STARTED ON INSULIN. 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 | 0627604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |