BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD A HIGH RES SSP

    MDR report key: 4912952 · Received July 10, 2015

    Report

    Report Number
    2244574-2015-00094
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    LIFE TECHNOLOGIES
    Product Code
    MZI
    PMA / PMN Number
    BK070038
    Removal / Correction Number
    2244574-008-2015 C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REPLICATED THE CUSTOMER'S OBSERVATION 06/09/2015. THE INVESTIGATION CONCLUDED ON 06/16/2015 AND WAS UNABLE TO DETERMINE WHETHER THE RESULT IS RELATED TO THE SPECIFIC DNA SAMPLE OR REFLECTIVE OF INCORRECT LABELING ON THE REACTIVITY FOR THE ALLELE. LIFE TECHNOLOGIES USED A RETAIN KIT AND TESTED A SAMPLE RETURNED BY THE CUSTOMER IN SSP ANALYSIS. RESULTS WERE OBTAINED ON 06/09/2015. THE CLINICAL CONSEQUENCES OF A MIS-TYPE OF THE AFFECTED ALLELES ARE MINIMAL TO NON-EXISTENT. IN ADDITION, THE AFFECTED ALLELE IS VERY RATE IN THE GENERAL POPULATION AND IS EXPECTED TO BE IN LESS THAN 0.01% OF THE DNA SAMPLES TESTED.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO CUSTOMER COMPLAINT (B)(4) MADE AGAINST ALLSET GOLD A HIGH RES SSP (SKU 54010D, LOT 012 1608823), SINCE THIS LOT (LISTED IN C. 6.) CONTAINS THE SAME AFFECTED PRIMER MIX. THE CUSTOMER REPORTED THAT THE REACTIVITY FOR LANE 86 WAS NEGATIVE FOR THE A03:20 ALLELE WHEN THE LABELING INDICATES THE REACTIVITY SHOULD BE POSITIVE. THE LABELING DISCREPANCY MAY LEAD TO POTENTIALLY MISTYPING AN A03:20 ALLELE AS AN A03:01 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448448 ALLSET GOLD A HIGH RES SSP MZI TEST, QUALITATIVE FOR HLA MZI LIFE TECHNOLOGIES 012 1608903

    Patients

    Seq Age Sex Outcome Treatment
    1