BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD A*23/24 HIGH RES

    MDR report key: 3879718 · Received April 7, 2014

    Report

    Report Number
    2244574-2014-00175
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    Removal / Correction Number
    2244574-2014-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION OF COMPLAINT (B)(4) FOR CATALOG #54160D, ALLSET GOLD A*23/24 HIGH RES, LOT #002 1256850 CONFIRMS A FALSE NEGATIVE IN LANE 33 WITH AN ALLELE THAT REPRESENTS AN A*23:05 IN DEFINED EXON REGIONS. ROOT CAUSE WAS AN INCORRECT ASSIGNMENT OF THE PRIMER MIX A23-20 AS POSITIVE FOR THIS ALLELE. CATALOG #54160D, ALLSET GOLD A*23/24 HIGH RES, LOT #002 1379885 HAS BEEN IDENTIFIED AS BEING IMPACTED BY THIS ISSUE. KIT DOCUMENTATION FOR CATALOG #54160D, ALLSET GOLD A*23/24 HIGH RES WILL BE UPDATES TO CHANGE REACTIVITY OF PRIMER MIX A23-20 FROM POSITIVE TO NEGATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A FALSE NEGATIVE IN LANE 33 OF ALLSET GOLD A*23/24 HIGH RES ITEM 54160D LOT 002 1256850 WHEN TESTING AN A*23:05 SAMPLE. THE SAME SAMPLE WAS TESTED WITH SEQUENCING FOR A RESULT OF A*02:01:01:01, A*23:05 AND WITH LUMINEX SSO THE SAME RESULT WAS FOUND WITH AN AMBIGUITY BETWEEN A*23:05 AND A*23:01:01. THIS MAY RESULT IN A MISTYPE. ((B)(4)). CATALOG #54160D, ALLSET GOLD A*23/24 HIGH REST, LOT#002 1379885 HAS BEEN IDENTIFIED AS BEING IMPACTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207084 ALLSET GOLD A*23/24 HIGH RES MZI TEST, QUALITATIVE FOR HLA, NON-D MZI LIFE TECHNOLOGIES CORP 002 1379885

    Patients

    Seq Age Sex Outcome Treatment
    1