BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1 SSP UNITRAY

    MDR report key: 2544952 · Received April 18, 2012

    Report

    Report Number
    2244574-2012-00003
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    December 12, 2011
    Report Date
    April 17, 2011
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    K020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. DRB1 HIGH RES SSP UNITRAY KITS HAVE A FALSE NEGATIVE IN LANE 44 FOR (B)(4) ALLELE. THE CUSTOMER REPORTED THAT, IN COMPARISON WITH A COMPETITOR'S SSO PRODUCT, THE DRB1 PRODUCT WAS NEGATIVE IN LANE 44 FOR (B)(4). THE (B)(4) ALLELE HAS A MISMATCH IN THE PRIMER'S TARGETED SEQUENCE AND SAMPLE SPECIFIC FUNCTIONALITY COULD NOT BE CONFIRMED THROUGH TESTING. THE (B)(4) ALLELE REACTIVITY IS ASSIGNED ACCORDING TO THE COMMON ALLELES IN THAT MOLECULAR GROUP. THE PRIMER MIX WAS NOT TESTED WITH A (B)(4)SAMPLE PRIOR TO THE COMPLAINT; THE LABELING STATED THE PRIMERS IN LANE 44 WOULD AMPLIFY THIS SEQUENCE IN THE (B)(4) ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRB1 SSP UNITRAY MZI TEST, QUALITATIVE FOR HLA, NON-DIAG MZI LIFE TECHNOLOGIES CORPORATION 4515010 017 845070

    Patients

    Seq Age Sex Outcome Treatment
    1