BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TOTAL HCG (THCG)

    MDR report key: 1220560 · Received October 30, 2008

    Report

    Report Number
    1219913-2008-00081
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    SIEMENS HELATHCARE DIAGNOSTICS, INC.
    Product Code
    JHI
    PMA / PMN Number
    K925277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOTAL HCG RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOWER THAN EXPECTED ADVIA CENTAUR TOTAL HCG PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED IT BE RETESTED. UPON REPEAT, THE HCG RESULT WAS POSITIVE. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN. THE CUSTOMER THEN RERAN THE POUR OFF TUBE AND RAN THE ORIGINAL SAMPLE TUBE AND OBTAINED A POSITIVE RESULT FOR BOTH. CUSTOMER ALSO REPEATED OTHER THCG SAMPLES FROM THAT SAME RUN AND ALL REPEATED CORRECTLY. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, DUE TO THE FALSE NEGATIVE TOTAL HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TOTAL HCG (THCG) TOTAL HCG IMMUNOASSAY JHI SIEMENS HELATHCARE DIAGNOSTICS, INC. NA 192

    Patients

    Seq Age Sex Outcome Treatment
    1