BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT)

    MDR report key: 1844942 · Received September 20, 2010

    Report

    Report Number
    1219913-2010-00107
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON TWO PT SAMPLES. BOTH THE PT SAMPLES WERE (B)(6) FOR (B)(6) ON THE ADVIA CENTAUR. THE LABORATORY PRACTICE IS TO CONFIRM (B)(6) SAMPLES WITH THE (B)(6) ASSAY. THE CUSTOMER REPEATED TESTING FOR THE PT SAMPLES ON A DIFFERENT METHOD AND THE RESULTS FOR (B)(6) WERE (B)(6). THE RESULTS FOR THE (B)(6) ASSAY WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Additional Manufacturer Narrative · 2

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    (B)(6) ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON TWO PT SAMPLES. BOTH THE PT SAMPLES WERE (B)(6) FOR (B)(6) ON THE ADVIA CENTAUR. THE LABORATORY PRACTICE IS TO CONFIRM (B)(6) SAMPLES WITH THE (B)(6) ASSAY. THE CUSTOMER REPEATED TESTING FOR THE PT SAMPLES ON A DIFFERENT METHOD AND THE RESULTS FOR (B)(6) WERE (B)(6). THE RESULTS FOR THE (B)(6) ASSAY WERE NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) HBCT IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 034

    Patients

    Seq Age Sex Outcome Treatment
    1
    2