BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT, SLIDE

    MDR report key: 6769042 · Received August 4, 2017

    Report

    Report Number
    3005967741-2017-00023
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 7, 2017
    Report Date
    August 4, 2017
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SEQUENCING INTERPRETATION: AN ALLELE COMBINATION THAT IS ATYPICAL (HOMOZYGOUS BB AT 1006 WHILE 733 IS HETEROZYGOUS) TRIGGERED A "PV" ON V WHICH IS NECESSARY TO DETERMINE IF A VARIANT C IS PRESENT [C (+)*]. THIS WAS THE SOURCE OF THE DISCREPANCY, SINCE SOME SEROLOGICAL REAGENTS WILL DETECT THIS AS C-POSITIVE, HOWEVER IT IS NOT THE CANONICAL RHC ANTIGEN.1,2. THE RHD TESTING SUPPORTS THIS AND THAT A VARIANT C [C(+)*] IS PRESENT. THE ATYPICAL ALLELE COMBINATION ON HEA PRECLUDED THE TEST'S ABILITY MAKE THE C(+)* CALL DEFINITIVELY SINCE THE VARIANT C OCCURS IN TRANS WITH ANOTHER RHCE VARIANT WHICH CAUSED THE PV ON V. RESULTS FROM BOTH THE HEA AND RHD BEADCHIP ALSO PREDICT A V- STATUS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE DONOR IS C- USING THE BIOARRAY HEA MOLECULAR BEADCHIP KIT; SEROLOGY RESULTS WERE C+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549620 HEA 1.2 BEADCHIP KIT, SLIDE HEA 1.2 BEADCHIP KIT, SLIDE PEP BIOARRAY SOLUTIONS LTD. 800-20202-08 17-233-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1