BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE

    MDR report key: 3664213 · Received January 23, 2014

    Report

    Report Number
    2244574-2014-00164
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Report Date
    June 13, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK-070038
    Removal / Correction Number
    004-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL INVESTIGATION CONFIRMS CUSTOMER INCIDENT OF LANE 95 BASE PAIR SELECTION NOT LIMITING RESULTS TO EITHER DR4 OR DR5 BASE ON SELECTION OF 85 BP OR 210 BP RESULT. THIS IS A KNOWN DEFECT OF THE UNIMATCH SOFTWARE WHEN USING A UCH FILE WHERE THE "^" SYMBOLS ARE PRESENT IN THE DRB4/DRB5 MIX. THE PRESENCE OF THE "^" SYMBOL BREAKS THE SIZE FILTERING FUNCTION OF UNIMATCH WHICH RESULTS IN BOTH DRB4 AND DRB5 DISPLAYED IN THE RESULTS REGARDLESS OF THE PRODUCT SIZE ENTERED BY THE USER. DCO1035227 RELEASED ON (B)(4) 2012 CONTAINED NEW UCH FILES UPDATING THE REACTIVITY OF DRB1X04:33 IN LANE 44 OF THE DRB1 KIT. THE UCH FILES RELEASED IN DC01035227 WERE DONE SO WITHOUT THE REQUIRED MANUAL EDITS TO REMOVE THE "^" SYMBOLS IN LANE 95. DISPOSITION IS TO USE AS IS. A CUSTOMER NOTIFICATION WAS SENT ON (B)(4) 2012 TO AFFECTED CUSTOMERS PROVIDING INSTRUCTIONS ON HOW TO OBTAIN CORRECTED DOCUMENTS FROM THE WEBSITE. ROOT CAUSE IS DETERMINED TO BE AN ERROR IN THE MANUAL PROCESS OF CREATING THIS FUNCTIONALITY WHEN GENERATING THE KIT DATABASE IN HOSII.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING USING THE ALLSET GOLD SSP HLA-DRB1 HIGH RES KIT (CATALOG#: 54040D, LOT #: 017 904113) THAT THE DRB1 LANE 95 BASE PAIR FILTER DID NOT FUNCTION PROPERLY. RESULTS WERE NOT LIMITED TO EITHER DR4 OR DR5. THIS WOULD RESULT IN A MISTYPE. ((B)(4)). A 4515110 DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE, LOT #017 904113 1013359 HAS BEEN IDENTIFIED AS ALSO HAVING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55441 DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE MZI TEST, QUALITATIVE FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 017 904113 1013359

    Patients

    Seq Age Sex Outcome Treatment
    1