BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP TEST KIT

    MDR report key: 16846135 · Received May 1, 2023

    Report

    Report Number
    3005967741-2023-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    April 3, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BIOARRAY SOLUTIONS, LIMITED
    Product Code
    MAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE 09OCT2023: THE SEQUENCING RESULT DETERMINED THAT THE MOLECULAR PRESENCE OF CYTOSINE AT THE POLYMORPHIC SITE C.307C AND GUANINE AT THE POLYMORPHIC SITE C.676G ARE INDICATIVE OF RHC(+), RHE(+) ANTIGENS1 FROM THE RHCE*01 (RHCE*CE) ALLELE, WHICH ARE CONSISTENT WITH THE SEROLOGY TYPING AND PHENOTYPES FROM THE RHCE BEADCHIP. THE RHC(+) IN SEQUENCING IS DISCORDANT WITH RHC(0) IN HEA 1.2 BEADCHIP, WHICH IS LIKELY DUE TO THE INTERFERING C.150A IN THE RHCE EXON 2 PRIMER BINDING REGION FROM THE FORWARD SEQUENCING READ AND IT IS ABSENT IN THE REVERSE SEQUENCING READ. THE SEQUENCING INVESTIGATION ALSO IDENTIFIES SIMILAR INTERFERENCE OF C.180A FOR C.180T IN THE EXON 2 OF THE RHCE GENE. PRESENCE OF THE UNANTICIPATED MUTATION IN THE PRIMER REGION COULD RESULT IN THE FALSE NEGATIVE CALL, WHICH IS LISTED AS A LIMITATION OF THE HEA 1.2 BEADCHIP PACKAGE INSERT.

    Description of Event or Problem · 0

    OUR TECHNICAL SUPPORT TEAM IN FRANCE RECEIVED A COMPLAINT FOR DISCREPANCY OF RESULTS BETWEEN HEA 1.2 BEADCHIP SLIDE KIT AND RHCE KIT. THERE IS A DISCORDANCE IN THE RHC ANTIGEN. UPDATE 09OCT2023: THE TEST REPORT WAS PROVIDED TO BIOARRAY FOR REVIEW, AND IT WAS CONFIRMED THAT THE PATIENT DONOR TYPE C POSITIVE (+) WITH RHCE/SEROLOGY AND C NEGATIVE (-) WITH HEA 1.2 BEADCHIP.

    Description of Event or Problem · 0

    OUR TECHNICAL SUPPORT TEAM IN FRANCE RECEIVED A COMPLAINT FOR DISCREPANCY OF RESULTS BETWEEN HEA 1.2 BEADCHIP SLIDE KIT AND RHCE KIT. THERE IS A DISCORDANCE IN THE RHC ANTIGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827214 HEA 1.2 BEADCHIP TEST KIT HEA BEADCHIP KIT MAO BIOARRAY SOLUTIONS, LIMITED 800-10202-08 22-15-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown