BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERACLONE ANTI-N (MNS2)

    MDR report key: 2003151 · Received February 3, 2011

    Report

    Report Number
    9610824-2011-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SENT US TWO VIALS OF THE COMPLAINED LOT OF REAGENT. IN THE QUALITY CONTROL LABORATORY THE COMPLAINED SAMPLE WAS TESTED WITH DIFFERENT N NEGATIVE RED CELLS. SOME OF THESE CELLS REACTED FALSE POSITIVE.

    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 ORTHO SCREENING CELLS: LOT 3SS313, EXP 01/11/2011