BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-N (MNS2)

    MDR report key: 2101915 · Received May 5, 2011

    Report

    Report Number
    9610824-2011-00055
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSF
    PMA / PMN Number
    125225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WEAK FALSE POSITIVE REACTIONS OF N NEGATIVE CELLS FROM THEIR CELL PANEL OF A COMPETITOR WITH SERACLONE ANTI-N ART. - NO. 808415, LOT 1934140. CUSTOMER COULD SEND US NEITHER VIALS OF THE COMPLAINED LOT NOR THE AFFECTED CELL PANEL OF THE COMPETITOR. TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION GIVES NO HINTS OF IRREGULARITIES THAT MIGHT HAVE AFFECTED NEGATIVELY THE SPECIFICITY OF THE COMPLAINED LOT. DUE TO THE CONFIRMED COMPLAINT, A RISK ANALYSIS WAS PERFORMED. ON THE BASIS OF THE RESULT OF THE RISK ANALYSIS WE DECIDED THAT NO MARKET RELATED ACTIVITIES ARE NECESSARY. A CAPA WAS INITIATED TO INTENSIFY THE EFFORTS TO FIND THE ROOT CAUSE FOR THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERACLONE ANTI-N (MNS2) SERACLONE ANTI-N KSF BIO-RAD MEDICAL DIAGNOSTICS GMBH 1934140

    Patients

    Seq Age Sex Outcome Treatment
    1 EXP. DATE 04/15/2011 AND 04/29/2011.| IMMUCOR PANEL CELLS: LOTS 06695 AND 08720,