BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEG

    MDR report key: 2554404 · Received May 1, 2012

    Report

    Report Number
    1034569-2012-00083
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    April 2, 2012
    Report Date
    May 1, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSG
    PMA / PMN Number
    BK910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW LOT OF PEG WAS SHIPPED TO THE CUSTOMER. NEGATIVE RESULTS WERE OBTAINED. THE CUSTOMER WASHES MANUALLY AND MAY NOT BE ADEQUATELY WASHING CELLS. THE WEAKNESS OF THE REACTIONS ON THE ECHO, AND THE LACK OF REACTIVITY IN GEL, POINT TO THE FACT THAT THIS IS A WEAK EXPRESSION OF THE ANTIBODY WHICH MAY BE BELOW THE THRESHOLD OF REACTIVITY, ESPECIALLY IF LESS THAN OPTIMAL TEST CONDITIONS EXIST. THE FOLLOWING LIMITATIONS SECTION LOCATED IN THE PACKAGE INSERT WAS REVIEWED WITH THE CUSTOMER: "POLYETHYLENE GLYCOL HAS A TENDENCY TO PRECIPITATE SERUM GLOBULINS. ACCORDINGLY, WHEN USING GAMMA PEG TO DETECT UNEXPECTED ANTIBODIES, IT IS ESPECIALLY IMPORTANT TO ASSURE THAT THE RED BLOOD CELLS ARE THOROUGHLY RESUSPENDED IN EACH CHANGE OF SALINE DURING THE WASHING PHASES OF THE TEST." THE PRODUCT IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING UNEXPECTED NEGATIVE REACTIONS IN MANUAL TESTING USING PEG FOR ANTIBODIES THAT WERE WEAKLY REACTIVE ON THE GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG ANTIBODY POTENTIATING REAGENT KSG IMMUCOR, INC. 336017

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR