BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-D (RH1) BLEND

    MDR report key: 2101863 · Received April 19, 2011

    Report

    Report Number
    9610824-2011-00049
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    125223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE CORRECT FUNCTION OF THE COMPLAINED LOT OF SERACLONE ANTI-D (RH1) BLEND. THE REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOT. WE HAD NOT FURTHER COMPLAINTS RELATED TO THIS LOT OF SERACLONE ANTI-D (RH1) BLEND.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED WEAK REACTIONS OR FALSE NEGATIVE REACTIONS OF RH(D) POSITIVE SAMPLES WITH SERACLONE ANTI-D (RH1) BLEND. WE ARE STILL WAITING FOR SAMPLES AND THE COMPLAINED PRODUCT. THE RETENTION SAMPLE OF SERACLONE ANTI-D (RH1) BLEND WAS TESTED WITH DIFFERENT RH (D) POSITIVE SAMPLES AND REACTED CORRECTLY AND STRONG POSITIVE. THE POTENCY TESTING OF RETENTION SAMPLE CONFIRMED THE REQUIRED MINIMUM TITER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-D (RH1) BLEND SERACLONE ANTI-D BLEND KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 7032070-05

    Patients

    Seq Age Sex Outcome Treatment
    1