BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN I AND II

    MDR report key: 5320251 · Received December 22, 2015

    Report

    Report Number
    1034569-2015-00215
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 23, 2015
    Report Date
    December 21, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: PLATE X43301158 PROCESSED WITH CRIC LOT 221513 (23NOV2015). CELL 1_ RS 16/NEG, CELL 2_RS 19/NEG; BOTH CELLS VISUALLY NEGATIVE WITH SLIGHT RED CELL ADHERENCE SAMPLE RESULTED AS NEGATIVE. PLATE X43301164 PROCESSED WITH CRIC LOT 221505 (18NOV2015). CELL 1_RS 18/NEG, CELL 2_RS 35/POS; CELL 1 VISUALLY NEGATIVE, CELL 2 VISUALLY POSITIVE SAMPLE RESULTED AS POSITIVE. PI LAB CONFIRMED THE REACTIVITIES OF THE E AND JKA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN I AND II, LOT X433 USING THE NEO WITH RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221513, ANTI-E, LOT DL20750, AND ANTI-JKA, LOT 614007-1. CONTROLS PERFORMED AS EXPECTED AND ALL CELL REACTED AS EXPECTED. RETENTION PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WITH THE CAPTURE-R READY-SCREEN I AND II (CRRS I/II) WHEN TESTING A PATIENT SAMPLE. THE SAMPLE WAS TESTED ON THE GALILEO NEO AND RESULTED WITH A NEGATIVE SCREEN. THE SAMPLE WAS IDENTIFIED TO HAVE AN ANTI-E AND ANTI-JKA AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845585 CAPTURE-R READY-SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X433

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR