BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BGEM TEST CARD

    MDR report key: 3303668 · Received August 14, 2013

    Report

    Report Number
    3004959793-2013-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    November 13, 2012
    Report Date
    March 22, 2013
    Manufacturer
    EPOCAL INC.
    Product Code
    KHP
    PMA / PMN Number
    K093297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EPOCAL INC HAS INITIATED A CORRECTIVE ACTION FOR THIS COMPLAINT. A FIELD ACTION HAS ALSO BEEN INITIATED. RESULTS ARE PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A GLUCOSE RESULT FROM EPOC SYSTEM LOWER THAN LAB, SAMPLES DRAWN AT SAME TIME, PATIENT SEEN IN EMERGENCY DEPARTMENT. NO FURTHER INFORMATION WAS AVAILABLE FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389053 EPOC BGEM TEST CARD BLOOD GAS ELECTROLYTE METABOLITE (BGEM) KHP EPOCAL INC. CT-1002-00-00 07-12276-00

    Patients

    Seq Age Sex Outcome Treatment
    1