BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECORE LOC A SEQ KIT

    MDR report key: 3459018 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00042
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A CUSTOMER AT (B)(6) REPORTED SEEING POOR DATA QUALITY AND ELEVATED BACKGROUND WHEN USING SECORE LOCUS A SEQUENCING KIT (CATALOG# 5300025). HIGH BACKGROUND WOULD GIVE THE CUSTOMER A NO TYPE RESULT. CUSTOMER COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528969 SECORE LOC A SEQ KIT MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP 1314715

    Patients

    Seq Age Sex Outcome Treatment
    1