BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5866506 · Received August 10, 2016

    Report

    Report Number
    1034569-2016-00197
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Date of Event
    July 14, 2016
    Report Date
    August 10, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REMOTE REVIEW OF CUSTOMER'S INSTRUMENT IMAGES: SAMPLE ID: (B)(6) (ANTI-D) BATCH 6389 - R746 AND 221661; 2 OF 2 RESULTED AS NEGATIVE. CELL 1_NEG, CELL 2_NEG, CELL 3_NEG; CELLS 1 AND 2 SHOW LIGHT RED CELL ADHERENCE, VISUALLY POSITIVE. CELLS 1 & 2 ARE RH POS. UNEXPECTED REACTIVITY ON CELLS 1 AND 2. THE PATIENT SAMPLE WAS RETESTED: A SYNOPSIS OF THE TESTING FOR SAMPLE (B)(4) (ANTI-D) ON BATCH 12725 IS AS FOLLOWS: (B)(6). NO UNEXPECTED REACTIVITY IS NOTED FOR THIS SAMPLE. A REAGENT PROBLEM DOES NOT APPEAR TO BE EVIDENT FOR SAMPLES (B)(6) AS REPEAT TESTING USING THE SAME REAGENT LOTS REACTED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE USING CAPTURE-R READY-SCREEN (3) (CRRS 3) ON THE GALILEO ECHO. THE PATIENT HAS A HISTORY OF ANTI-D. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE MISSED ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518877 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R746 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR