BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN I AND II

    MDR report key: 5574018 · Received April 13, 2016

    Report

    Report Number
    1034569-2016-00071
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 13, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000648
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE NEO. NEO SN (B)(4) FILE REVIEW SUMMARY: NO ERRORS PRESENT IN EVENT LOG DURING TIME OF TESTING X439: CELL 2 IS C+(HOMOZYGOUS) SAMPLE ID: (B)(6): CELL 1: NEGATIVE VISUALLY NEGATIVE, CELL 2 EQUIVOCAL VISUALLY NEGATIVE. PI LAB CONFIRMED THE REACTIVITY OF THE C ANTIGEN ON CELL 2, OF RETENTION CAPTURE-R READY-SCREEN I AND II, LOT X439, ON THE NEO USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221589 WITH ANTI-C, LOT 6K7221500. CONTROLS PERFORMED AS EXPECTED AND CELLS REACTED AS EXPECTED. RETENTION PERFORMED AS EXPECTED. OUR INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THE CUSTOMER ISSUE WAS NOT REPRODUCED OR CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A SAMPLE WITH CAPTURE-R READY-SCREEN I AND II (CRRS I AND II) ON A GALILEO NEO INSTRUMENT. PATIENT HAS AN ANTI-C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230288 CAPTURE-R READY-SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X439 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR