BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECORE B LOCUS SEQUENCING KIT - SINGLE AMPLIFI

    MDR report key: 3459034 · Received October 15, 2013

    Report

    Report Number
    2244574-2013-00044
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Report Date
    September 16, 2013
    Manufacturer
    LIFE TECHNOLOGIES CORP
    Product Code
    MZI
    PMA / PMN Number
    BK110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION FOR SECORE B LOCUS SEQUENCING KIT - SINGLE AMPLIFICATION SYSTEM (CATALOG# 5311025D) IS ON-GOING AS OF (B)(4)2 013 AND ADDITIONAL INFORMATION WILL BE SUBMITTED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A CUSTOMER AT THE (B)(6) FILED A COMPLAINT WITH LIFE TECHNOLOGIES CORP DISTRIBUTER (B)(4). THE CUSTOMER REPORTED SEEING HIGH BACKGROUND IN RESULTS WHEN USING SECORE B LOCUS SEQUENCING KIT - SINGLE AMPLIFICATION SYSTEM (CATALOG# 5311025D). 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
    529287 SECORE B LOCUS SEQUENCING KIT - SINGLE AMPLIFI MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN MZI LIFE TECHNOLOGIES CORP 1215275

    Patients

    Seq Age Sex Outcome Treatment
    1