BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1*15 SSP UNITRAY KIT

    MDR report key: 3702708 · Received January 9, 2014

    Report

    Report Number
    2244574-2014-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Removal / Correction Number
    013-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED TO VERIFY HOW THE PRIMER REACTIVITIES ASSIGNED WITHIN THE INTERNAL LEGACY SCORE DATABASE WERE INTERPRETED WITHIN THE CURRENT HOS (HUMAN OLIGOTYPING SOFTWARE) DATABASE. THE INVESTIGATION SHOWED THERE WERE NO OTHER INCORRECT PRIMER REACTIVITIES, HOWEVER, THE INVESTIGATION IDENTIFIED THAT SOME OF THE PRIMER REACTIVITY ASSIGNMENTS WERE INCONSISTENT BETWEEN PRIMER MIXES. THE INCONSISTENCY IS DUE TO NEW ALLELIC INFORMATION BEING AVAILABLE NOW, WHICH WAS NOT AVAILABLE AT THE TIME WHEN THE INFORMATION WAS INITIALLY TRANSFERRED FROM THE SCORE DATABASE TO HOS DATABASE IN 2008. THROUGH THIS INVESTIGATION, ONE OF THE PRIMER REACTIVITIES THAT WERE IDENTIFIED AS NEEDING HARMONIZATION HAD REACTION PATTERNS ON THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH SOFTWARE THAT MAY BE INTERPRETED AS A POTENTIAL MIS-TYPE ASSIGNMENT FOR DRB1X 15:34 ALLELE AS DRB1X16:01:02 AND DRB1X15:54:66 ALLELE AS DRB1X15:25. AS A PRODUCT MAINTENANCE FUNCTION, THE PRIMER REACTIVITIES WERE UPDATED IN THE HOS DATABASE AND ON THE DATA INTERPRETATION WORKSHEETS AND UNIMATCH SOFTWARE. A CUSTOMER NOTIFICATION WAS ISSUED TO INFORM CUSTOMERS OF THE CHANGE TO THE REACTIVITY PATTERNS SHOWN ON THE LABELING WORKSHEETS AND UNIMATCH SOFTWARE.

    Description of Event or Problem · 1

    A DISCREPANCY IN TYPING RESULTS USING DRB1X15 SSP UNITRAY KIT (CATALOG #450102D, LOT 011 1274159) WAS REPORTED IN INTERNAL COMPLAINT # (B)(4). IT WAS DISCOVERED THAT PRIMER MIX R15C, WHICH IS INCLUDED IN LANE 5 OF DRB1X15 SSP UNITRAY KIT (CATALOG #450102D, LOT 011 1274159, HAS BEEN SHOWN TO PRODUCE A NEGATIVE REACTION IN THE PRESENCE OF THE DRB1X15:34/54/66 ALLELES. AS A RESULT OF THE NEGATIVE REACTION A SAMPLE CONTAINING DRB1X15:34 ALLELE COULD MISTYPE AS A DRB1X16:01:02 AND A SAMPLE CONTAINING DRB1X15:54/66 ALLELE COULD MISTYPE AS DRB1X15:25. THE INVESTIGATION OF INTERNAL COMPLAINT # (B)(4) IDENTIFIED DRB1X15 SSP UNITRAY KIT, CATALOG #450102D, LOT #010 743202 AS A PRODUCT AFFECTED BY THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17230 DRB1*15 SSP UNITRAY KIT MZI TEST, QUALITIATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 010 743202

    Patients

    Seq Age Sex Outcome Treatment
    1