BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-02 SSP UNITRAY W/TAQ 12 TST

    MDR report key: 4619183 · Received March 17, 2015

    Report

    Report Number
    2244574-2015-00016
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 27, 2015
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO CUSTOMER COMPLAINT (B)(4) MADE AGAINST ANOTHER PRODUCT, ALLSET GOLD A HIGH RES SSP, CATALOG #54010D. THE CUSTOMER REPORTED THAT THE REACTIVITY FOR LANE 17 AND LANE 21 WERE BOTH NEGATIVE WHEN THE LABELING INDICATES THE REACTIVITY SHOULD BE POSITIVE. THE LABELING DISCREPANCY MAY LEAD TO POTENTIALLY MISTYPING AN A 30:16 ALLELE AS AN A 30:01 ALLELE AND FALSE POSITIVE CALLS FOR ALLELES A 03:09 AND A 11:06. THE COMPLAINT HAS BEEN CONFIRMED AND IN ADDITION TO THE PRODUCT AGAINST WHICH THE COMPLAINT WAS LODGED, IT WAS FOUND THAT PRODUCT 470214D A-02 SSP UNITRAY W/TAQ 12 TEST LOT 014 1357609 143335, THE SUBJECT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182661 A-02 SSP UNITRAY W/TAQ 12 TST MZI EST, QUALITATIVE FOR HLA MZI 01413576091433355

    Patients

    Seq Age Sex Outcome Treatment
    1