BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLSET GOLD SSP HLA-ABDRDQ LOW RES KIT - 10

    MDR report key: 3435320 · Received October 2, 2013

    Report

    Report Number
    2244574-2013-00025
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    August 23, 2013
    Report Date
    September 4, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    HXA
    PMA / PMN Number
    K070038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION IDENTIFIED THAT THE REACTIVITY ASSIGNMENT IN OUR HUMAN OLIGOTYPING SOFTWARE (HOS) PROGRAM FOR A32:04 ALLELE IN PRIMER MIX PM019E WAS DETERMINED TO BE INCORRECT. PRODUCT LABELING WITH PRIMER MIX PM019E WILL BE UPDATED TO REMOVE SPECIFICITY FOR THE A*32:04 ALLELE. ADDITIONAL INVESTIGATION ACTIVITIES ARE STILL ONGOING AND WILL BE REPORTED IN THE 30-DAY REPORT.

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF A*32:04 WAS CORRECTED IN IMGT ALIGNMENT 200905 (ORIGINAL DESIGN ALIGNMENT) AND 201207 (ALLELE UPDATE ALIGNMENT AT THE TIME). DEVELOPMENT OF ABC LOT 038 WAS ONGOING AT THE TIME OF THE CORRECTION IN IMGT ALIGNMENT 201101. HOS ALLELE REACTIVITY IS MANAGED IN EACH IMGT ALIGNMENT VERSION INDEPENDENTLY. THE REACTIVITY OF A*32:04 WAS CORRECTED IN 200905 AND 201201, BUT THE REACTIVITY WAS NOT CORRECTED IN THE 201101 IMGT ALIGNMENT FOR THE LOT IN DEVELOPMENT. WHILE THERE ARE CURRENTLY KIT REACTIVITY COMPARISONS INCLUDED IN THE SSP REVISION PROCESS TO IDENTIFY UNINTENDED REACTIVITY CHANGES THAT OCCUR DURING DEVELOPMENT, THERE IS NO MECHANISMS IN PLACE TO IDENTIFY IF REACTIVITY CORRECTIONS MADE TO RELEASED PRODUCT HAVE OCCURRED WHICH WOULD AFFECT THE DEVELOPMENT LOT. CAPA 136041 THE R&D SSP KIT REVISION INSTRUCTIONS AND REVIEW FORM WILL BE UPDATED TO INCLUDE A MECHANISM FOR EVALUATING REACTIVITY CHANGES ACROSS IMGT ALIGNMENT VERSIONS TO ENSURE ALL CURRENT REACTIVITY DECISIONS ARE REFLECTED IN THE LOTS PRIOR TO DESIGN TRANSFER. UPDATE SSP KIT DESIGN IN HOS TO INCLUDE A COMPARISON OF REACTIVITIES FROM THE ORIGINAL DESIGN ALIGNMENT OF A CURRENT LOT TO THE CURRENT ALLELE. UPDATE IMGT TO ENSURE NO CORRECTIONS HAVE OCCURRED THAT WERE NOT UPDATED IN THE DESIGN ALIGNMENT. UPDATE SSP KIT RELEASE REVIEW FROM HOS TO DESCRIBE HOW TO REVIEW THE REACTIVITY COMPARISON UPDATE SSP KIT RELEASE REVIEW FROM HOS TO INCLUDE A REVIEW SIGNATURE FOR THE KIT COMPARISON.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ALLSET GOLD SSP HLA-ABDRDQ LOW RES KIT - 10 TESTS (CATALOG #54360D LOT #029 1255127 1345427) WILL PRODUCE AN INCORRECT LOW RESOLUTION TYPING OR MISTYPE RESULT IN LANE 39 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 POSITIVE 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 PR #(B)(4). THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH .UCH FILES FOR THE AFFECTED LOT HAS BEEN CORRECTED. IT HAS BEEN DETERMINED THAT ROOT CAUSE IS DUE TO INCORRECT LABELING. CORRECTION: (B)(4).

    Description of Event or Problem · 1

    THIS EVENT WAS A RESULT OF THE INTERNAL COMPLAINT INVESTIGATION FOR PROBLEM REPORT PR# (B)(4). THE REACTIVITY ASSIGNMENT IN OUR HUMAN OLIGOTYPING SOFTWARE (HOS) PROGRAM FOR A32:04 ALLELE IN PRIMER MIX PM019E WAS DETERMINED TO BE INCORRECT. SEVERAL LOTS OF AB/DR/DQ SSP UNITRAY W/TAQ (CATALOG# 7850110) WERE AFFECTED BY THE INCORRECT A32:04 ALLELE ASSIGNMENT. THE KITS WILL PRODUCE AN INCORRECT LOW RESOLUTION TYPING OR MISTYPING RESULT OF A*02, A*03 ALLELES WHEN TESTING A SAMPLE WHICH HAS THE A*32:04 ALLELE. THE USER WILL BE UNAWARE OF THE INCORRECT TYPE, UNLESS THEY CONFIRM THE SAMPLE TYPING BY ANOTHER METHOD , THEREFORE, THIS WOULD BE CONSIDERED A MISTYPE.

    Description of Event or Problem · 1

    DURING THE INVESTIGATION OF INTERNAL COMPLAINT #(B)(4) (ALLSET GOLD SSP HLA-ABC LOW RES 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. ALLSET GOLD SSP HLA-ABDRDQ LOW RES KIT - 10 TESTS CATALOG #54360D #029 1255127 1345427) WOULD ALSO BE AFFECTED BY THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498943 ALLSET GOLD SSP HLA-ABDRDQ LOW RES KIT - 10 MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN HXA LIFE TECHNOLOGIES CORPORATION 0291255127 1345427

    Patients

    Seq Age Sex Outcome Treatment
    1