BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC SSP UNITRAY KIT WITH TAQ

    MDR report key: 2495453 · Received March 8, 2012

    Report

    Report Number
    2244574-2012-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    December 12, 2011
    Report Date
    March 7, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ONE COMPLAINT HAS BEEN RECEIVED. ABC UNITRAY SSP KITS HAVE A FALSE NEGATIVE IN LANE 13. THE CUSTOMER REPORTED THAT, IN COMPARISON WITH A COMPETITOR'S SSP PRODUCT, THE ABC SSP UNITRAY WAS NEGATIVE IN LANE 13 FOR A TYPING OF A 32:04. LANE 13 WAS LISTED ON THE KIT WORKSHEET/INTERPRETATION DOCUMENTATION (WHICH IS INCLUDED WITH EACH KIT) AS THE FOLLOWING: A 32:04^, HOWEVER THE DOCUMENTATION ALSO INDICATED THAT "ALLELES WRITTEN WITH THE "^" SYMBOL FOLLOWING THEM HAVE UNK SEQUENCES AT THE SENSE AND / OR ANTISENSE PRIMER ANNEALING SITE. THEIR REACTION PATTERNS ARE PREDICTED BASED ON SEQUENCE HOMOLOGY WITH EACH MAJOR GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC SSP UNITRAY KIT WITH TAQ MZI TEST, QUALITATIVE FOR HLA, NON-DIAGN IYO LIFE TECHNOLOGIES CORPORATION 7800110 037 979628

    Patients

    Seq Age Sex Outcome Treatment
    1