BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECORE C LOCUS SEQUENCING KIT

    MDR report key: 3704692 · Received January 17, 2014

    Report

    Report Number
    2244574-2014-00045
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 16, 2013
    Manufacturer
    LIFE TECH CORP
    Product Code
    MZI
    PMA / PMN Number
    BK110038
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECORE C LOCUS SEQUENCING KIT, CATALOG #5320025, LOT #1183024 IS ON-GOING.

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING HIGH BACKGROUND AND NORMAL SIGNAL STRENGTH IN MULTIPLE LOTS OF SECORE KITS A, B, C, AND DRB1. THIS WOULD RESULT IN A NO TYPE. CUSTOMER COMPLAINT WAS REPORTED TO MFR REP. SECORE C LOCUS SEQUENCING KIT, CATALOG #5320025, LOT #1183024 HAS BEEN IDENTIFIED IN THE COMPLAINT AS HAVING THIS PROBLEM. ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46194 SECORE C LOCUS SEQUENCING KIT MZI TEST, QUALITATIVE FOR HLA, NON-D MZI LIFE TECH CORP 1183024

    Patients

    Seq Age Sex Outcome Treatment
    1