BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TESTOSTERONE (TSTO) ASSAY

    MDR report key: 2001813 · Received February 22, 2011

    Report

    Report Number
    1219913-2011-00019
    Event Type
    Other
    Date Received
    February 22, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDZ
    PMA / PMN Number
    K934562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT LOW TESTOSTERONE RESULT IS UNK. THE SYSTEM ERROR LOG NOTED A VOLUME CHECK ERROR FOR REAGENT PROBE 2. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE REPLACED THE ACID PUMP, HOWEVER, NO CONCLUSION CAN BE DRAWN. THE INSTRUMENTS ARE PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR TESTOSTERONE RESULT WAS OBTAINED ON A PT SAMPLE WHEN COMPARED TO REPEAT TESTING. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TESTOSTERONE (TSTO) ASSAY TESTOSTERONE IMMUNOASSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 151

    Patients

    Seq Age Sex Outcome Treatment
    1