BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECHO LUMENA

    MDR report key: 12254079 · Received July 30, 2021

    Report

    Report Number
    1034569-2021-00020
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Report Date
    July 30, 2021
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234002338
    PMA / PMN Number
    BK170135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBERS#: (B)(4). ADDITIONAL LOT NUMBERS: ID410, DN129, 221768, ID415, R247.

    Description of Event or Problem · 1

    A REVIEW OF THE EVENTS INDICATED THAT THIRTEEN (13) PATIENT SAMPLES TESTED ON THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED INACCURATE RESULTS. A REVIEW INDICATED THAT THE ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM PRODUCED FOUR (4) UNEXPECTED FALSE NEGATIVE RESULTS FOR THE ANTI-FYA ANTIBODY; THREE (3) FOR THE ANTI-E ANTIBODY; TWO (2) FOR THE ANTI-K ANTIBODY; ONE (1) FOR THE ANTI-LUB ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY; ONE (1) FOR THE ANTI-C ANTIBODY AND ONE (1) FOR THE ANTI-E ANTIBODY. SUBSEQUENT TESTING OF REAGENT RETENTION LOTS, REVIEWS OF DESIGN HISTORY RECORDS AND REAGENT ANTIGEN VALIDATION TESTING OF THE INITIAL BULK PRODUCT USED FOR COMMERCIAL VIALING SHOWED ACCEPTABLE RESULTS. THROUGH POST EVENT TESTS AND INVESTIGATIONS, NO SPECIFIC CAUSES WERE DETERMINED FOR THE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154089 ECHO LUMENA AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 0086998 ID411,DN128,ID413,R232,R243 10888234002338

    Patients

    Seq Age Sex Outcome Treatment
    1