BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE BEADCHIP TEST HEA

    MDR report key: 4245276 · Received November 12, 2014

    Report

    Report Number
    3005967741-2014-00001
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 10, 2014
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FALSE POSITIVE AND/OR INVALID RESULTS MAY BE GENERATED IN RARE CASES WHERE A SAMPLE CONTAINS EXAMPLES OF MOLECULAR EVENTS THAT AFFECT THE BLOOD-GROUP ANTIGEN EXPRESSION AND PHENOTYPES AND THE NUCLEOTIDE CHANGES ASSOCIATED WITH THESE EVENTS ARE NOT EXPLICITLY MONITORED BY THE ASSAY. EXAMPLES INCLUDE DNA-SEQUENCE VARIATIONS INCLUDING PREMATURE STOP CODON, SNP LEADING TO MISSENSE CHANGE IN AMINO ACID, HYBRID GENES, MODIFYING GENES; CHANGES AT THE RNA TRANSCRIPTION LEVEL INCLUDING ALTERNATIVE SPLICING; REDUCED PROTEIN EXPRESSION, ETC. KNOWN PHENOTYPES ARE KNULL, JKNULL (JKNULL HAS A PREVALENCE OF UP TO 9% AMONG POLYNESIANS), RHNULL, RH HYBRIDS, KMOD, CO(A-,B-), IN(LU), LU(A-,B-) AND GP HYBRIDS. PRESENCE OF A C.179_180DEL (SER60FS) MUTATION LINKED WITH THE FY(B) ALLELE MAY CHANGE THE FY(B) ANTIGEN EXPRESSION AND LEAD TO A FALSE POSITIVE RESULT. IN THIS CASE THE PATIENT WAS REPORTED TO BE AF ASIAN DECENT. BLOOD SAMPLE WAS SENT FOR SEQUENCING ON (B)(6) 2014. AWAITING SEQUENCING RESULTS.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT A PATIENT SAMPLE TYPED JKB+ BY IVD HEA ASSAY, HOWEVER, TYPED JKB BY SEROLOGY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730017 PRECISETYPE BEADCHIP TEST HEA PRECISETYPE BEADCHIP TEST / HEA PEP BIOARRAY SOLUTIONS LTD. 800-20202-08 14-54

    Patients

    Seq Age Sex Outcome Treatment
    1