BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TOXO IGG

    MDR report key: 2171754 · Received July 22, 2011

    Report

    Report Number
    3002809144-2011-00517
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LGD
    PMA / PMN Number
    K954575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION WAS CONDUCTED TO INVESTIGATE THIS ISSUE. SINCE NO RETURNED MATERIALS WERE AVAILABLE FOR THE EVALUATION, A RETAINED KIT OF THE PRODUCT IN QUESTION WAS CALIBRATED AND THE CALIBRATION MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. THE PRODUCT SENSITIVITY WAS ALSO EVALUATED AND WAS WITHIN MANUFACTURING SPECIFICATIONS. THE COMPLAINT RECORDS FOR THE LOT NUMBER IN QUESTION WAS REVIEWED WITH NO ISSUES IDENTIFIED RELATED TO THIS OBSERVATION. BASED ON THE EVALUATION RESULTS, IT WAS DETERMINED THAT THIS PRODUCT IS PERFORMING WITHIN SPECIFICATIONS AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE CUSTOMER WAS INSTRUCTED TO PERFORM A SECOND SEROLOGICAL METHOD FOR IGG ANTIBODIES. WHEN POSITIVE RESULTS ARE OBTAINED WITH THE TWO METHODS, A SUBSEQUENT SERUM SAMPLE TAKEN THREE WEEKS LATER IS TESTED, SO AS TO VERIFY THE PRESENCE OF A POSITIVE AND STABLE TITER OF ANTI T. GONDII IGG ANTIBODIES. IN CASE OF DISCORDANT RESULTS, THE CUSTOMER WAS ADVISED TO CONSIDER THE PATIENT NON IMMUNE AND PERFORM A SEROLOGICAL FOLLOW-UP DURING THE PREGNANCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE (PREGNANT WOMAN) WITH A HISTORY OF POSITIVE RESULTS FOR THE TOXOPLASMA IGG (ON A NON-ABBOTT METHOD) GENERATED FALSE NEGATIVE RESULTS ON THE AXSYM ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOXO IGG LGD ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER 7A83-78