BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAT-A-COUNT FREE TESTOSTERONE

    MDR report key: 3286892 · Received August 14, 2013

    Report

    Report Number
    2017183-2013-00001
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    January 14, 2012
    Report Date
    January 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CDZ
    PMA / PMN Number
    K844423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL OPERATIONS CONFIRMED THAT INTERNAL TESTING OF RIA FREE TESTOSTERONE KIT LOTS 1458, 1462, AND 1463 HAD BEEN PERFORMED AND ALL THREE KITS WERE RELEASED WITHIN THE MANUFACTURER SPECIFICATIONS. SIEMENS GLOBAL PRODUCT SUPPORT HAS NOT RECEIVED COMPLAINTS FROM ANY OTHER CUSTOMERS ABOUT RIA FREE TESTOSTERONE KIT LOTS 1458, 1462, AND 1463. DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE PHYSICIAN(S) WHO HAD QUESTIONED THE LOW RESULTS HAVE NOT HAD ANY MORE QUESTIONS OR CONCERNS ABOUT RESULTS OBTAINED. THE CAUSE OF THE DISCORDANT, FALSELY LOW FREE TESTOSTERONE RESULTS IS UNKNOWN. (08/14/2013) NOTE: THIS MDR WAS FILED AS 2432235-2013-00046 FEBRUARY 1, 2013. THE CORRECT NUMBER IS 2017183-2013-00001, AS THE LEGAL MANUFACTURER IS THE SITE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2017183-2013-00001 WAS FILED ON AUGUST 14, 2013. CORRECTION (08/28/2013): DURING REVIEW OF THE INITIAL MDR, IT WAS DISCOVERED THAT THE PRODUCT CODE IN WAS LISTED AS 'CDX'. THE CORRECT PRODUCT CODE FOR RIA FREE TESTOSTERONE IS CDZ.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW FREE TESTOSTERONE RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN RIA INSTRUMENT USING COAT-A-COUNT FREE TESTOSTERONE LOTS 1458, 1462, AND 1463. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AT A REFERENCE LABORATORY, AND HIGHER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW FREE TESTOSTERONE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393259 COAT-A-COUNT FREE TESTOSTERONE RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE CDZ SIEMENS HEALTHCARE DIAGNOSTICS INC. COAT-A-COUNT FREE TESTOSTERONE 1458; 1462; 1463

    Patients

    Seq Age Sex Outcome Treatment
    1