BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE BEADCHIP TEST HEA

    MDR report key: 4303862 · Received December 8, 2014

    Report

    Report Number
    3005967741-2014-00002
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    October 16, 2014
    Report Date
    December 8, 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

    PACKAGE INSERT LIMITATION: "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 (B)(6) DECENT. BLOOD SAMPLE WAS SENT FOR SEQUENCING ON (B)(6) 2014. AWAITING SEQUENCING RESULTS. (B)(6) 2014 - SEQUENCING RESULTS REVEALED THAT THE SAMPLE HAD THE JK NULL MUTATION, WHICH IS LISTED AS A LIMITATION IN OUR PRECISE TYPE HEA TEST AS STATED IN THE LIMITATIONS SECTION OF THE PACKAGE INSERT. ABOVE YOU WILL FIND A DIRECT QUOTATION FROM THE LIMITATION SECTION OF THE PACKAGE INSERT. PLEASE REFER TO ATTACHED COMPLAINT REPORT SUMMARY FOR DETAILS ON 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. THIS IS A SUPPLEMENTAL REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790116 PRECISETYPE BEADCHIP TEST HEA PRECISETYPE BEADCHIP TEST / HEA PEP BIOARRAY SOLUTIONS LTD. 800-20202-08 14-54

    Patients

    Seq Age Sex Outcome Treatment
    1