BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-N (MNS2)

    MDR report key: 2513168 · Received February 9, 2011

    Report

    Report Number
    9610824-2011-00262
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 9, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WEAKLY FALSE POSITIVE REACTIONS OF N NEGATIVE CELLS FROM THEIR CELL PANEL OF A COMPETITOR WITH SERACLONE ANTI-N ART. -NO. (B)(4), LOT 1934140. THE CUSTOMER USES THE CELL PANEL AS CONTROL CELLS. THE CUSTOMER HAS SENT US VIALS OF THE COMPLAINED LOT OF REAGENT AND THE AFFECTED CELL PANEL OF THE COMPETITOR. THE TESTING OF THE QUALITY CONTROL LABORATORY CONFIRMED THE FALSE POSITIVE REACTIONS OF CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1