BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAK12

    MDR report key: 5078641 · Received September 15, 2015

    Report

    Report Number
    2183608-2015-00002
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 15, 2015
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MYP
    PMA / PMN Number
    BK950004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIVE CUSTOMER COMPLAINTS WERE RECEIVED ((B)(4)) DESCRIBING PAK12 LOT 3002648 IS GENERATING INVALID ASSAYS DUE TO HIGH NEGATIVE CONTROL VALUES. PER THE PAK12 IFU, THE AVERAGE NEGATIVE CONTROL VALUES FOR THE GPIIB/IIIA ROWS MUST BE </= 0.175 OD. AN INVESTIGATION WAS PERFORMED WHICH INCLUDED TESTING NEGATIVE CONTROL (LOT 3002552) AND THE PAK12 KIT (LOT 3002648). THE INVESTIGATION TEST RESULTS CONFIRMED INCREASES IN NEGATIVE CONTROL OD VALUES OCCURRED. INVESTIGATION TESTING RULED OUT THE NEGATIVE CONTROL MATERIAL (NC LOT 3002552) . FURTHER INVESTIGATION AND REVIEW WAS PERFORMED TO IDENTIFY A PROBABLE ROOT CAUSE. THE INVESTIGATION AND REVIEW LED TO THE PROBABLE ROOT CAUSE BEING A MANUFACTURING EVENT WHICH AFFECTED THE PLATES (MICROWELL STRIPS). THE EVENT IS SPECIFIC TO ONE LOT OF MANUFACTURED PRODUCT, PAK12 LOT 3002648. KITS DISTRIBUTED FROM THIS LOT OF PRODUCT WERE NOT DISTRIBUTED IN THE US. KITS DISTRIBUTED FROM THIS LOT OF PRODUCT WERE DISTRIBUTED IN THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609899 PAK12 PAK12 MYP IMMUCOR GTI DIAGNOSTICS, INC. NA 3002648

    Patients

    Seq Age Sex Outcome Treatment
    1