BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD SSP HLA-B17 HIGH RES KIT - 10 TEST

    MDR report key: 3710225 · Received January 15, 2014

    Report

    Report Number
    2244574-2014-00134
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Report Date
    May 31, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Removal / Correction Number
    006-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION HAS CONFIRMED THAT PRIMER MIX B-086 FOUND ON LANE 9 IN THE ALLSET GOLD SSP HLA-B17 LOCUS HIGH RES KIT - 10 TESTS (CATALOG #541120D LOT #004 841439) WILL GIVE A (B)(4) FOR THE B47:03 ALLELE IN THE AFFECTED PRODUCT ACCORDING TO THE LABELING. THE LABELING STATED THE PRIMERS IN PRIMER MIX B-086 WOULD AMPLIFY THIS SEQUENT IN THE B47:03 ALLELE. ROOT CAUSE HAS BEEN DETERMINED TO THE PRODUCT DESIGN (INCORRECT LABELING).

    Description of Event or Problem · 1

    IT WAS REPORTED IN CUSTOMER COMPLAINT #(B)(4) THAT A SURVEY SAMPLE TESTED WHEN USING B LOCUS HIGH RES SSP UNITRAY KIT (CATALOG #4730010, LOT #009 984375) RESULTED IN B47:02 WHEN THE RESULT SHOULD HAVE BEEN B47:03 ((B)(4)). CATALOG #541120D ALLSET GOLD SSP HLA-B17 LOCUS HIGH RES KIT - 10 TESTS, LOT #004 841439 HAS BEEN IDENTIFIED AS PRODUCT THAT WOULD BE AFFECTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41738 ALLSET GOLD SSP HLA-B17 HIGH RES KIT - 10 TEST MZI TEST, QUALITATIVE FOR HLA, NON-D MZI LIFE TECHNOLOGIES CORP 004 84139

    Patients

    Seq Age Sex Outcome Treatment
    1