BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CW HIGH RES SSP UNITRAYS KIT WITH TAQ

    MDR report key: 2432862 · Received January 11, 2012

    Report

    Report Number
    2244574-2012-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    October 3, 2011
    Report Date
    January 10, 2012
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    MZI
    PMA / PMN Number
    BK020068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    USING A SURVEY SAMPLE, THE CUSTOMER REPORTED THAT THERE WAS A FALSE POSITIVE BAND SEEN IN LANE 89 FOR A CONFIRMED SAMPLE TYPE OF HLA C 02:14. LANE 89 WAS LISTED ON THE KIT WORKSHEET/INTERPRETATION DOCUMENTATION (WHICH IS INCLUDED WITH EACH KIT) AS THE FOLLOWING: C 02:10^, 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 HEMOLOGY WITH EACH MAJOR HLA GROUP. INTERNAL INVESTIGATION CONFIRMED BY SEQUENCE BASED TYPING THAT THE CUSTOMER HAD A C 02:14 ALLELE. THEREFORE LANE 89 HAS A CONFIRMED FALSE POSITIVE IN THE AFFECTED KITS. THE C 02:14 ALLELE HAS AN UNK SEQUENCE REGION WHICH HAD NOT BEEN CONFIRMED THROUGH TESTING. IT IS NOW KNOWN THAT THE C 02:14 ALLELE HAS THE SAME POLYMORPHISM AS C 02:10 AND THE WORKSHEET IS INCORRECT IN LISTING THIS ALLELE AS NEGATIVE FOR LANE 89. WHEN AN ALLELE, SUCH AS THE C 02:14 ALLELE, CONTAINS A REGION WITH UNK DNA SEQUENCE, IT IS ASSIGNED ACCORDING TO THE COMMON ALLELES IN THAT MOLECULAR HLA GROUP. NO C02:14 SAMPLE WAS AVAILABLE FOR TESTING PRIOR TO THE COMPLAINT; THE LABELING STATED THE PRIMERS IN LANE 89 WOULD NOT AMPLIFY THIS SEQUENCE IN THE C 02:14 ALLELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CW HIGH RES SSP UNITRAYS KIT WITH TAQ MZI TEST, QUALITATIVE, FOR HLA, NON-DIAGNOSTIC MZI LIFE TECHNOLOGIES CORPORATION 005 928442

    Patients

    Seq Age Sex Outcome Treatment
    1