BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1943141 · Received December 30, 2010

    Report

    Report Number
    2954323-2010-01933
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 30, 2010
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAIN SAMPLES OF PRECISION TEST STRIP LOTS MANUFACTURED WITH HOT-MELT GLUE BATCHES EXHIBITED LOWER THAN EXPECTED READINGS ON CONTINUOUS STORAGE AFTER NINE MONTHS AT 30 DEGREES CELSIUS DURING ROUTINE STABILITY PERFORMANCE TESTING. THIS STABILITY ISSUE COULD LEAD TO THE GENERATION OF INCORRECTLY DEPRESSED BLOOD GLUCOSE RESULTS AND THESE ERRONEOUS RESULTS MAY BE IN THE C, D, OR E ZONES OF PARKES ERROR GRID, AND AS SUCH, HAVE THE POTENTIAL TO BE CLINICALLY SIGNIFICANT. THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. (B)(4). NOTE: THE METER IS DESIGNED TO DISPLAY READINGS OF 20 MG/DL TO 500 MG/DL. THIS METER DOES NOT SHOW A NUMERIC VALUE GREATER THAN 500 MG/DL. A BLOOD GLUCOSE READING ABOVE 500 MG/DL WILL READ AS A "HI" IN THE ADC METER. NOTE: THE DEVICE MANUFACTURE DATE FOR TEST STRIP LOT 46336 IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WITHIN 10 MINUTES WHILE USING AN AFFECTED TEST STRIP LOT. RESULTS OF 99 MG/DL, 495 MG/DL, 98 MG/DL, AND 501 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 46336

    Patients

    Seq Age Sex Outcome Treatment
    1