BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR PROGESTERONE (PRGE)

    MDR report key: 2230971 · Received September 1, 2011

    Report

    Report Number
    1219913-2011-00119
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 9, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JLS
    PMA / PMN Number
    K932955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT PROGESTERONE RESULTS IS UNKNOWN. IMPROPER HANDLING OR STORAGE OF THE SAMPLES MAY BE A CAUSE OF THE DISCORDANT RESULTS BETWEEN THE TWO SITES. THE CALIBRATIONS AND QC WERE WITHIN ACCEPTABLE RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR PROGESTERONE RESULTS WERE OBTAINED FOR PATIENT SAMPLES. THE PROGESTERONE RESULTS WERE NOT IN AGREEMENT WITH THE ULTRASOUND AND A SECOND ADVIA CENTAUR INSTRUMENT AT A DIFFERENT SITE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR PROGESTERONE (PRGE) PROGESTERONE JLS SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 254

    Patients

    Seq Age Sex Outcome Treatment
    1