BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA PEG

    MDR report key: 1483939 · Received September 28, 2009

    Report

    Report Number
    1034569-2009-00325
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 25, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSG
    PMA / PMN Number
    BK910001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PACKAGE INSERT, NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN A CONCENTRATION TOO LOW TO BE DETECTED BY THE TEST METHOD EMPLOYED. THE CUSTOMER DOES NOT HAVE ANY SAMPLE TO SEND IN FOR INVESTIGATION TESTING. THE EVENT APPEARS TO BE DUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON A PATIENT SAMPLE. MANUAL TUBE TESTING USING PEG FOR ANTIBODY SCREEN AND PANEL WERE BOTH NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA PEG ANTIBODY POTENTIATING REAGENT KSG IMMUCOR 336010

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR