BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TESTOSTERONE (TSTO) ASSAY

    MDR report key: 3902846 · Received June 30, 2014

    Report

    Report Number
    1219913-2014-00161
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDZ
    PMA / PMN Number
    K133491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED A TOTAL SYSTEM CHECK AND RAN A CONTAMINATION CHECK. NO ISSUES WERE IDENTIFIED. THE CAUSE FOR THE DISCORDANT TESTOSTERONE RESULT IS UNKNOWN. INTERNAL DATA SHOWS THAT LOT # 072 IS PERFORMING WITHIN SPECIFICATIONS. SIEMENS HEALTHCARE DIAGNOSTICS, INC. IS INVESTIGATING AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00161 ON JUNE 30, 2014. 07/17/2014 ADDITIONAL INFORMATION: A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR TROUBLESHOOTING. THE FSE PERFORMED INSPECTIONS AND REPLACED PARTS (DILUTORS, VALVES, AND WASH SEPARATION MANIFOLD). QUALITY CONTROL WAS RUN AFTER THE PARTS WERE REPLACED. THE CUSTOMER IS NOT SATISFIED WITH THE LOW END PRECISION OF THE TESTOSTERONE ASSAY AND WILL DISCONTINUE RUNNING THE ASSAY ON THE ADVIA CENTAUR. THE CUSTOMER WAS INFORMED THAT: A SMALL INCREASE IN VARIATION (BETWEEN 0.5% AND 1.5% CV ACROSS THE ASSAY RANGE) CAN BE EXPECTED WITH LOT NUMBERS ENDING IN 170 AND ABOVE OF ADVIA CENTAUR TESTOSTERONE. THE PRECISION OF THE NEW ANTIBODY POOL IS WITHIN THE DESIGN OF THE ASSAY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION FO THE DEVICE IS REQUIRED. 08/06/2014 CORRECTION: LOT #072 IN THE INITIAL MDR REPORT. THE CORRECT LOT # IS 172.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR TESTOSTERONE (TSTO) RESULTS WERE OBTAINED FOR A PATIENT SAMPLE DURING LOT TO LOT CORRELATION STUDY. THE STUDY WAS WITH REAGENT LOT #171 AND LOT # 172. THE RESULT FOR THE PATIENT SAMPLE WAS LOWER WITH REAGENT LOT # 172. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379906 ADVIA CENTAUR TESTOSTERONE (TSTO) ASSAY TESTOSTERONE IMMUNOASSSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 172

    Patients

    Seq Age Sex Outcome Treatment
    1