BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 5644324 · Received May 10, 2016

    Report

    Report Number
    1034569-2016-00099
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 11, 2016
    Report Date
    May 9, 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
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT PERFORMED A REMOTE REVIEW OF THE INSTRUMENT CAMERA IMAGES: BATCH: 29745/ SAMPLE ID: (B)(6), LOTS IN USE: R715/221600, CELL 1 AND 3-NEGATIVE, VISUALLY NEGATIVE. CELL 2-NEGATIVE, VISUALLY WEAKLY POSITIVE WITH VERY SLIGHT RED CELL ADHERENCE NOTED. CONTROL RESULTED AS EXPECTED. (CELL 2 IS E+/E= AND ALL OTHER CELLS ARE E=/E+). BATCH 31960/ SAMPLE ID (B)(6), LOTS IN USE: R715/221600, CELL 1 AND 3-NEGATIVE, VISUALLY NEGATIVE. CELL 2-NEGATIVE, VISUALLY WEAKLY POSITIVE WITH VERY SLIGHT RED CELL ADHERENCE NOTED. CONTROL RESULTED AS EXPECTED. (CELL 2 IS E+/E= AND ALL OTHER CELLS ARE E=/E+) THE ISSUE WAS RESOLVED WHEN CUSTOMER RETESTED THE AFFECTED SAMPLE WITH A NEW LOT OF CRRS 3 WHICH RESULTED IN A 3+ REACTION FOR CELL 2 (E POSITIVE CELL). IMMUCOR PI LAB CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (3), LOT R715, ON THE ECHO, USING RETENTION CAPTURE-R READY INDICATOR RED CELL, LOT 221608 AND ANTI-E, LOT BA631. CONTROLS PERFORMED AS EXPECTED AND ALL CELLS REACTED AS EXPECTED.

    Description of Event or Problem · 1

    ON 1(B)(6) 2016, A CUSTOMER REPORTED UNEXPECTED NEGATIVE ANTIBODY SCREENS WHEN USING CAPTURE-R READY-SCREEN (3) (CRRS 3) ON A GALILEO ECHO INSTRUMENT. THE SAMPLE CONTAINS AN ANTI-E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300465 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R715 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR