BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3612968 · Received December 26, 2013

    Report

    Report Number
    2244574-2013-00259
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK000019
    Removal / Correction Number
    011-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABC SSP UNITRAY KIT WITH TAQ POLYMERASE (CATALOG #7800110 LOT 38 1221266 1353301) WILL PRODUCE AN INCORRECT LOW RESOLUTION TYPING OR MISTYPE RESULT IN LANE 13 FOR A 02, A 03 OR LIKE ALLELES WHEN TESTING A SAMPLE WHICH HAS THE A 32:04 ALLELE. THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES, CREATED WITH ALLELE ALIGNMENT 2011001, WERE NOT UPDATED WHEN ALL THE OTHER VERSIONS OF THE WORKSHEETS AND UNIMATCH .UCH FILES, ASSOCIATED WITH THE REACTIVITY FOR PRIMER PM019E, WERE UPDATED. THE UPDATES TO THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES FOR PRIMER PM019E, WERE COMPLETED AFTER INTERNAL INVESTIGATION DETERMINED THAT THE PREDICTED POSITIVES REACTIVITY OF PRIMER PM019E FOR THE A 32:04 ALLELE WAS INCORRECT. CHANGES TO PREDICTED REACTIVITY FOR PRIMER PM019E, WERE ORIGINALLY COMPLETED AS CORRECTION TO COMPLAINT REPORT (B)(4). THE DATA INTERPRETATION WORKSHEET AND UNIMATCH .UCH FILES FOR THE AFFECTED LOT HAS BEEN CORRECTED. IT HAS BEEN DETERMINED THAT ROOT CAUSE IS DUE TO INCORRECT LABELING.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF INTERNAL COMPLAINT (B)(4) (ALLSET GOLD SSP HLA-ABC LOW REST KIT, CATALOG #54340D, LOT 038 1391657), IT WAS DISCOVERED THAT TWO VERSIONS OF THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES ARE INCLUDED WITH EACH ALLSET GOLD OR UNITRAY KITS. THE OLDER VERSION OF THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES, DESIGNATED BY ALLELE ALIGNMENT 2011001, CONTAINED AN INCORRECT REACTIVITY ASSIGNMENT (INCORRECTLY IDENTIFIED AS POSITIVE) FOR PRIMER MIX PM019E. THE CURRENT VERSION OF THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES, DESIGNATED BY ALLELE ALIGNMENT 201301, CONTAINED THE CORRECT REACTIVITY ASSIGNMENT (CORRECTLY IDENTIFIED AS NEGATIVE) FOR PRIMER MIX PM019E. IF A CUSTOMER WERE TO USE THE OLDER VERSION OF THE DATA INTERPRETATION WORKSHEETS OR UNIMATCH .UCH FILES, DESIGNATED BY ALLELE ALIGNMENT 2011001, TO ANALYZING DATA FROM A SAMPLE WHICH CONTAINED THE A 32:04 ALLELE, A MISTYPE RESULT MAY BE OBTAINED. ABC SSP UNITRAY KIT WITH TAQ POLYMERASE (CATALOG #7800110 #38 1221266 1353301) WOULD ALSO BE AFFECTED BY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675910 ABC SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 0381221266 1357271

    Patients

    Seq Age Sex Outcome Treatment
    1