BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBP1 SSP UNITRAY KIT

    MDR report key: 2597139 · Received May 31, 2012

    Report

    Report Number
    2244574-2012-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    January 6, 2012
    Report Date
    May 31, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. LANES 27 AND 39 ARE COMING UP AS FALSE NEGATIVE FOR DPB1 126:01 ALLELE WITH THE DPB1 SSP UNITRAY KIT. INTERNAL INVESTIGATION IDENTIFIED A TREND OF THREE COMPLAINTS REGARDING LANES 27 AND 39 GIVING FALSE NEGATIVE RESULTS FOR A DPB1 126:01 ALLELE WHICH ARE UNDEFINED. CURRENTLY THERE ARE QC COMMENTS PROVIDED WITH THE KIT ABOUT THE PRIMERS IN THE AFFECTED LANES, STATING THAT THEY HAVE PREDICTED REACTIVITY. THE DPB1 126:01 ALLELE REACTIVITY IS ASSIGNED ACCORDING TO THE COMMON ALLELES. THE PRIMER MIXES HAVE NOT BEEN TESTED WITH A DPB1 126:01 SAMPLE; THE LABELING STATED THE PRIMERS IN LANES 27 AND 39 WOULD AMPLIFY THE TARGETED SEQUENCES IN THE DPB1 126:01 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBP1 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN IYO LIFE TECHNOLOGIES CORPORATION 451606D 008 979626

    Patients

    Seq Age Sex Outcome Treatment
    1