BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEA 1.2 BEADCHIP KIT, SLIDE

    MDR report key: 6855462 · Received September 11, 2017

    Report

    Report Number
    3005967741-2017-00025
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    July 14, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIOARRAY SOLUTIONS LTD.
    Product Code
    PEP
    UDI-DI
    10888234100065
    PMA / PMN Number
    BP130026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEQUENCING INTERPRETATION: THE HETEROZYGOSITY AT ALLELES PREDICTING THE M AND N ANTIGENS WOULD NORMALLY REPRESENTS A HETEROZYGOUS MN INDIVIDUAL. SEQUENCING HAS REVEALED A POSSIBLE GYP HYBRID ORIGINATING IN OR AROUND INTRON 2 (SEE RIGHT IMAGE ALIGNED TO GYPA AND GYPB REFERENCE SEQUENCES) THAT ABROGATED PRECISETYPE HEA TEST PRIMER BINDING LEADING TO A N- RESULT ON BEADCHIP HEAD2620_5. THIS ALSO LED TO ASYMMETRIC AMPLIFICATION OF SEQUENCING RESULTS (SEE LEFT IMAGE). GYP HYBRIDS ARE LISTED AS A LIMITATION OF THE PRECISETYPE HEA TEST.

    Additional Manufacturer Narrative · 0

    SEQUENCING INTERPRETATION: THE HETEROZYGOSITY AT ALLELES PREDICTING THE M AND N ANTIGENS WOULD NORMALLY REPRESENTS A HETEROZYGOUS MN INDIVIDUAL. SEQUENCING HAS REVEALED A POSSIBLE GYP HYBRID ORIGINATING IN OR AROUND INTRON 2 (SEE RIGHT IMAGE ALIGNED TO GYPA AND GYPB REFERENCE SEQUENCES) THAT ABROGATED PRECISETYPE HEA TEST PRIMER BINDING LEADING TO A N- RESULT ON BEADCHIP HEAD2620_5. THIS ALSO LED TO ASYMMETRIC AMPLIFICATION OF SEQUENCING RESULTS (SEE LEFT IMAGE). GYP HYBRIDS ARE LISTED AS A LIMITATION OF THE PRECISETYPE HEA TEST. - ATTACHMENT: [INVESTIGATION REPORT SUMMARY (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637081 HEA 1.2 BEADCHIP KIT, SLIDE HEA 1.2 BEADCHIP KIT, SLIDE PEP BIOARRAY SOLUTIONS LTD. 800-20202-08 16-320-V 10888234100065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown