BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-N (MNS2)

    MDR report key: 2902895 · Received January 9, 2013

    Report

    Report Number
    9610824-2012-00217
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR (B)(6) CONTACTED US WITH INFORMATION THAT ONE CUSTOMER IN (B)(6) REPORTED FALSE POSITIVE REACTIONS WITH SERACLONE ANTI-N. DESPITE SEVERAL INQUIRIES, WE DID NOT RECEIVE INFORMATION ON THE DANISH CUSTOMER'S IDENTITY, OR WHICH LOTS OF SERACLONE ANTI-N WERE AFFECTED NOR DID WE ABLE TO OBTAIN ANY INFORMATION ON THE DATE OF EVENT. NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE SAMPLES THAT HAD CAUSED FALSE POSITIVE TEST RESULTS WERE RETURNED BY THE CUSTOMER. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLES OF ALL THREE POSSIBLY AFFECTED LOTS OF SERACLONE ANTI-N. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. FURTHERMORE THE PH VALUE OF ALL THREE AFFECTED LOTS WAS MEASURED AND MET THE ACCEPTANCE CRITERION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOTS OF SERACLONE ANTI-N FUNCTION CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12305 BLOOD GROUPING REAGENT ANTI-N (MNS2) SERACLONE ANTI-N (MNS2) KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2126051, 2203111, 2213060

    Patients

    Seq Age Sex Outcome Treatment
    1