BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 2687407 · Received July 6, 2011

    Report

    Report Number
    3004959793-2011-00001
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 28, 2011
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT: THE LOT 07-11087 CONTAINS TEST CARDS ("AFFECTED" TEST CARDS) THAT CAUSE THE REPORTING OF GLUCOSE VALUES TO BE SIGNIFICANTLY LOWER THAN THE ACCURATE VALUE IN SAMPLES WHETHER GLUCOSE LEVELS ARE GREATER THAN 100MG/ML; SAMPLES WHERE GLUCOSE LEVELS ARE LESS THAN 100 MG/DL INCLUDING THE LOW END OF THE REPORTABLE RANGE ARE ACCURATELY REPORTED IN AFFECTED CARDS; THE PERCENTAGE OF AFFECTED TEST CARDS FROM THIS LOT IS NOT KNOWN HOWEVER IT IS KNOWN THAT THE MAJORITY OF TEST CARDS IN THIS LOT ARE NOT AFFECTED.

    Description of Event or Problem · 1

    ON THE (B)(6) 2011, A TECHNICAL SERVICE REQUEST, (B)(4), WAS LOGGED: "CUSTOMER REPORTED OUT OF RANGE RESULTS FOR GLUCOSE OBSERVED WHILE PERFORMING INCOMING QC TESTING ON A NEW LOT OF TEST CARDS. EUROTROL LEVEL 3 LOT 179-3-B040 WAS USED AS THE CONTROL SAMPLE. ACCEPTABLE RANGE (ACCORDING TO VALUE ASSIGNMENT DATA SHEET DOCUMENT # (B)(4)) IS 203-317 MG/DL. CUSTOMER OBSERVED THE FOLLOWING VALUES 155, 168, 148, 182, 167)". SUBSEQUENT INVESTIGATION SHOWED THAT THESE QC TESTS WERE RUN ON THE (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPOC BGEM TEST CARD CHL, CEM, JFP, JPI, JGS, CGA, KHP CHL EPOCAL INC. EPOC BGEM TEST CARD 07-11087-00

    Patients

    Seq Age Sex Outcome Treatment
    1