BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPB1 SSP UNITRAY 12 TEST

    MDR report key: 4176398 · Received July 24, 2014

    Report

    Report Number
    2244574-2014-00183
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    LIFE TECHNOLOGIES CORP.
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION OF (B)(4) DETERMINED THE ROOT CAUSE OF THIS INCIDENT IS THE INCORRECT ASSIGNMENT OF DPB1*33:01 ALLELE AS A POSITIVE REACTIVITY FOR PRIMER MIXES DPB027B AND DPB039A. KIT DOCUMENTATION FOR CATALOG # 451606D WILL BE UPDATED TO CHANGE THE ALLELE REACTIVITY OF THE PRIMER MIX.

    Description of Event or Problem · 1

    THE INTERNAL INVESTIGATION OF A CUSTOMER COMPLAINT (B)(4) IDENTIFIED AN INCORRECT ALLELE ASSIGNMENT OF THE DPB1 *33:01 ALLELE AS A POSITIVE REACTIVITY FOR PRIMER MIXES DPB027B AND DPB039A. THIS MAY CAUSE A MISTYPE RESULT FOR HLA TYPING. IT WAS DISCOVERED THAT DPB1 SSP UNITRAY 12 TESTS (CATALOG# 451606D, LOT 008 1190373) WAS AFFECTED BY THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434304 DPB1 SSP UNITRAY 12 TEST TEST, QUALITATIVE, FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORP. 008 1190373

    Patients

    Seq Age Sex Outcome Treatment
    1