BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1*15 SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3702682 · Received January 9, 2014

    Report

    Report Number
    2244574-2014-00010
    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 INFO BEING AVAILABLE NOW, WHICH WAS NOT AVAILABLE AT THE TIME WHEN THE INFO WAS INITIALLY TRANSFERRED FROM THE SCORE DATABASE TO HOS DATABASE IN 2008. THROUGH THIS INVESTIGATION, ONE OF THE PRIMER REACTIVITIES THAT WAS IDENTIFIED AS NEEDING HARMONIZATION HAD REACTION PATTERNS ON THE DATE INTERPRETATION WORKSHEETS AND UNIMATCH SOFTWARE THAT MAY BE INTERPRETED AS A POTENTIAL MIS-TYPE ASSIGNMENT FOR DRB1* 15:34 ALLELE AS DRB1*16:01:02 AND DRB1* 15:54/66 ALLELE AS DRB1*15:25. 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 PATTERS SHOWN ON THE LABELING WORKSHEETS AND UNIMATCH SOFTWARE.

    Description of Event or Problem · 1

    A DISCREPANCY IN TYPING RESULTS USING DRB1*15 SSP UNITRAY KIT (CATALOG # 450102D, LOT 011 1274159) WAS REPORTED IN INTERNAL COMPLAINT #PR(B)(4). IT WAS DISCOVERED THAT PRIMER MIX R15-05C, WHICH IS INCLUDED IN LANE 5 OF DRB1*15 SSP UNITRAY KIT (CATALOG #450102D, LOT 011 1274159, HAS BEEN SHOWN TO PRODUCE A NEGATIVE REACTION IN THE PRESENCE OF THE DRB1*15:34/54/66 ALLELES. AS A RESULT OF THE NEGATIVE REACTION A SAMPLE CONTAINING DRB1*15:34 ALLELE COULD MISTYPE AS A DRB1*16:01:02 AND A SAMPLE CONTAINING DRB1*15:54/66 ALLELE COULD MISTYPE AS DRB1*15:25. THE INVESTIGATION OF INTERNAL COMPLAINT #PR(B)(4) IDENTIFIED DRB1*15 SSP UNITRAY KIT WITH TAQ POLYMERASE, CATALOG #450112D, LOT #010 743202 807163 AS A PRODUCT AFFECTED BY THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17465 DRB1*15 SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORPORATION 010 743202 807163

    Patients

    Seq Age Sex Outcome Treatment
    1