BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 4769834 · Received May 13, 2015

    Report

    Report Number
    1034569-2015-00078
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 13, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLICATED PRODUCT CAPTURE-R READY INDICATOR RED CELL, LOT 221353, EXPIRED PRIOR TO BEING REFERRED TO PI. PRODUCT WAS NOT USED TO CONFIRM REACTIVITY OF D NOR A C ANTIGEN WHILE IN DATE. DHR REVIEW PERFORMED FOR CRRIRC LOT 221353 FOR PERFORMANCE ON THE ECHO PRIOR TO RELEASE. QUALITY CONTROL - FINAL RELEASE: ECHO INSTRUMENTATION: PERFORMED ON (B)(6) 2015. SCREEN ASSAY PERFORMED; CONTROLS RESULTED AS EXPECTED. WBCORQC TUBE 2 CONTAINS ANTI D. IT WAS 4+ POSITIVE. FOUR REPLICATES OF CAPTURE-R NEGATIVE CONTROL, LOT 245150, RESULTED NEGATIVE AS EXPECTED. FOUR REPLICATES OF CAPTURE-R POSITIVE CONTROL (WEAK), LOT 244310, RESULTED POSITIVE AS EXPECTED. FOUR REPLICATES OF KNOWN ANTIBODY NEGATIVE (INERT) IN-HOUSE DONORS RESULTED NEGATIVE AS EXPECTED. DOCUMENTATION STATES THAT ALL WELLS WERE VISUALLY VERIFIED. CAPTURE R INDICATOR CELL POTENCY TESTING WAS PERFORMED ON (B)(6) 2015. TITER FOR ANTI-D WAS 1:64. UNABLE TO RULE OUT COMPROMISED VIAL OF CRRIC ((B)(4)). ISSUE WAS RESOLVED WITH NEW VIAL OF CRRIC ((B)(4)) WITH CRRS LOT R584.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE RESULTS WERE OBTAINED WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY-SCREEN (3) ON THE GALILEO ECHO USING CAPTURE-R READY-INDICATOR RED CELLS (CRRIRC) LOT 221353, WHEN TESTED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312018 CAPTURE-R READY INDICATOR RED CELLS ANTI-IGG COATED RED BLOOD CELLS KSZ IMMUCOR, INC. 221353

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR