BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TOTAL HCG (THCG)

    MDR report key: 1163232 · Received September 15, 2008

    Report

    Report Number
    1219913-2008-00064
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHI
    PMA / PMN Number
    K925277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD APPLICATION SPECIALIST AND FIELD SERVICE ENGINEER (FSE) WERE SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSE POSITIVE RESULT MAY BE PRE-ANALYTICAL CONTAMINATION OF THE SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POSITIVE ADVIA CENTAUR THCG PATIENT RESULT TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT FIT WITH THE CLINICAL PICTURE OF THE PATIENT. AS A RESULT, TWO SERUM (SST) SAMPLES (ORIGINAL AND SECONDARY) WERE RETRIEVED AND BOTH WERE RUN ON A DIFFERENT ADVIA CENTAUR SYSTEM. THE ORIGINAL THCG SAMPLE RESULTS WERE POSITIVE. THE SECONDARY THCG SAMPLE RESULTS WERE NEGATIVE. THE ORIGINAL SAMPLE THAT WAS REPORTED AS POSITIVE WAS RETESTED ON AN ALTERNATIVE METHOD AND THE HCG RESULT WAS POSITIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE THCG RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1