BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSP UNITRAY KIT HR HLA-DQB1 WITH TAQ

    MDR report key: 3963276 · Received June 18, 2014

    Report

    Report Number
    2244574-2014-00180
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER REPORT, THE USER OF SSP UNITRAY KIT HR HLA-DQB1 WITH TAQ (CATALOG NUMBER 451414, LOT NUMBER 0151312016) MAY RESULT IN A MISTYPE. THE EVALUATION OF THIS DEVICE IS CURRENTLY IN PROGRESS. RESULTS ARE PENDING THE EVALUATION COMPLETION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DISCREPANT TESTING RESULT BETWEEN UNITRAY DQB1 HR (SKU 451414) AND THEIR COLLABORATOR'S SEQUENCING ASSAY. THE ORIGINAL RESULT OBTAINED BY UNITRAY DQB1 HR WAS DQB1 03:03. THE RESULT OBTAINED BY SEQUENCING WAS DQB1 03:30. REPEAT TESTING USING UNITRAY DQB1 HR RESULTED DQB1 03:30 WITH A WEAK POSITIVE IN LANE 24. THE TEST WAS REPEATED 2 MORE TIMES, RESULTING IN ONE INSTANCE OF DQB1 03:03 AND 1 OF DQB1 03:30, AGAIN WITH A VERY WEAK LANE 24 POSITIVE BAND. THIS EVENT MAY RESULT IN A MISTYPE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356925 SSP UNITRAY KIT HR HLA-DQB1 WITH TAQ TEST, QUALITATIVE FOR HLA, NON-DIAGNOS MZI LIFE TECHNOLOGIES CORPORATION 015 1312016

    Patients

    Seq Age Sex Outcome Treatment
    1