BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISETYPE HEA MOLECULAR BEADCHIP TEST

    MDR report key: 12972702 · Received December 9, 2021

    Report

    Report Number
    3005967741-2021-00007
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    October 18, 2021
    Report Date
    February 22, 2022
    Manufacturer
    BIOARRAY SOLUTIONS
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE BEADCHIP (B)(4) (PERFORMED ON (B)(6) 2021), THE RESULT FOR THE KIDD SYSTEM DEPICTED AS JKA-JKB+. BESIDES, CUSTOMER PERFORMED THE SAMPLE TESTING WITH DIFFERENT MOLECULAR PLATFORM, WHICH IS RT-PCR, IT SHOWED JKB - (B)(4).

    Additional Manufacturer Narrative · 0

    SANGER SEQUENCING DETERMINE THAT THE INDIVIDUAL IS HOMOZYGOUS FOR JKB, JK (A-B+) AS REPORTED BY HEA BEADCHIP. HOWEVER, THE INDIVIDUAL IS ALSO POSITIVE FOR A POLYMORPHISM KNOWN FOR WEAKENING EXPRESSION OF THE JKB ANTIGEN, JK(B+W). IN ADDITION, THE INDIVIDUAL IS ALSO HOMOZYGOUS FOR A POLYMORPHISM WHICH IS A KNOWN SILENCING MUTATION THAT INHIBITS EXPRESSION OF JK ANTIGENS ON RED BLOOD CELLS; THEREFORE, THE JK(A-B-) RESULTS BY SEROLOGY. THIS LIMITATION IS ADDRESSED IN THE PACKAGE INSERT: 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.

    Description of Event or Problem · 0

    ON (B)(6) 2021 A CUSTOMER REPORTED DISCREPANCY IN DETECTING JKB ANTIGEN USING BEADCHIP((B)(4)) AND REQUESTED ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870839 PRECISETYPE HEA MOLECULAR BEADCHIP TEST MOLECULIAR ERYTHROCYTE TYPING TEST PEP BIOARRAY SOLUTIONS 800-20202-08 21-105-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown