BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRB1*15 SSP UNITRAY KIT

    MDR report key: 3624293 · Received December 9, 2013

    Report

    Report Number
    2244574-2013-00070
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    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

    INVESTIGATION IS ON-GOING. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 1

    DURING AN INTERNAL QUALITY CONTROL INVESTIGATION 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. PRIMER MIX REACTIVITY ASSIGNMENTS ARE USED TO CREATE THE DOCUMENTATION THAT IS INCLUDED WITHIN THE KIT AND USED BY THE CUSTOMER TO INTERPRET THE HLA TYPING OF THE SAMPLE. INTERNAL COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639753 DRB1*15 SSP UNITRAY KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORPORATION 011 1274159

    Patients

    Seq Age Sex Outcome Treatment
    1