BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2223684 · Received August 25, 2011

    Report

    Report Number
    2954323-2011-04295
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 25, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLES FROM TEST STRIP LOT 0822524 HAVE BEEN TESTED AND ONE OF EIGHT RETAIN VIALS WAS CONFIRMED TO ALSO PRODUCE LOW RESULTS WITH CONTROL SOLUTION TESTING. FURTHER OBSERVATION OBSERVED A SCRATCH IN THE CHANNEL OF THE CARBON SIDE OF THE STRIP. THE SCRATCH COMPLETELY SEVERS THE CHANNEL CAUSING AN ELECTRICAL "OPEN". THE LOCATION OF THE SCRATCH LEAVES HALF OF THE CARBON AREA TO CONDUCT CHARGE DURING THE REACTION, POTENTIALLY RESULTING IN A LOW READING. THESE ERRONEOUS RESULTS MAY OCCUR IN THE "C" ZONE OF THE PARKES ERROR GRID, AND AS SUCH, HAVE THE POTENTIAL TO BE CLINICALLY SIGNIFICANT. REMEDIAL ACTION 2954323-06/10/09-003-C WAS REPORTED TO THE (B)(6) DISTRICT OFFICE ON 10 JUN 2009. IT SHOULD BE NOTED THAT THE REPORTED TEST STRIPS EXPIRED IN AUGUST 2010.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING LOWER THAN HOW THEY FELT ON THEIR ADC METER WHILE USING FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS. 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 LITE GLUCOSE TEST STRIPS NBW 0822524

    Patients

    Seq Age Sex Outcome Treatment
    1