BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT, SLIDE

    MDR report key: 8116928 · Received November 29, 2018

    Report

    Report Number
    3005967741-2018-00016
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 29, 2018
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEQUENCING INTERPRETATION: THE MOLECULAR PRESENCE OF CYTOSINE AND THYMINE AT THE POLYMORPHIC SITE THAT IS INDICATIVE OF THE KELL (K/K) ANTIGEN WOULD NORMALLY REPRESENT A HETEROZYGOUS K/K INDIVIDUAL, AS WAS REPORTED BY HEA BEADCHIPS HEAE2536_7 AND HEAG4146_2. SEQUENCING UNCOVERED A KNOWN SILENCING (K0) MUTATION IN INTRON 3, KEL*02N.06 (KEL C.223+1G>A, RS369569464), WHICH SILENCES CELLANO (K) EXPRESSION2.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958129 HEA 1.2 BEADCHIP KIT, SLIDE HEA 1.2 BEADCHIP KIT, SLIDE PEP BIOARRAY SOLUTIONS LTD. 800-20202-08 17-184-C AND 18-362-C 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1