BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-S (MNS3)

    MDR report key: 2024232 · Received March 4, 2011

    Report

    Report Number
    9610824-2011-00027
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 3, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    LKJ
    PMA / PMN Number
    125216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE AFFECTED LOT OF SERACLONE ANTI-S. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE REACTION OF A BLOOD DONOR WITH SERACLONE ANTI-S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GROUPING REAGENT ANTI-S (MNS3) SERACLONE ANTI-S (MNS3) LKJ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7025110-01

    Patients

    Seq Age Sex Outcome Treatment
    1 IMMUCOR ANTI-S: LOT# 622002