BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP TOTAL HCG (THCG)

    MDR report key: 1946234 · Received December 28, 2010

    Report

    Report Number
    1219913-2010-00166
    Event Type
    Other
    Date Received
    December 28, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 24, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JHI
    PMA / PMN Number
    K925277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSE NEGATIVE TOTAL HCG RESULTS IS UNK. A SIEMENS REPRESENTATIVE EXAMINED THE TOTAL HCG QC AND CALIBRATIONS. NO ISSUES WERE FOUND. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR XP TOTAL HCG PT RESULT WAS OBTAINED FOR A PT SAMPLE. THE RESULT DID NOT MATCH THE URINE TEST AND WAS QUESTIONED. THE CUSTOMER PERFORMED TESTING THE NEXT DAY AND THE TOTAL HCG RESULT WAS A WEAK POSITIVE ON THE ADVIA CENTAUR XP. THE URINE TEST RESULT WAS POSITIVE. TESTING ON ANOTHER PT SAMPLE ABOUT A WEEK LATER YIELDED A POSITIVE RESULT WITH THE ADVIA CENTAUR XP. PT 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 XP TOTAL HCG (THCG) TOTAL HCG JHI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 235

    Patients

    Seq Age Sex Outcome Treatment
    1