BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP AFP ASSAY

    MDR report key: 1461670 · Received August 27, 2009

    Report

    Report Number
    1219913-2009-00086
    Event Type
    Other
    Date Received
    August 27, 2009
    Date of Event
    July 20, 2009
    Report Date
    August 4, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOK
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Additional Manufacturer Narrative · 2

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Additional Manufacturer Narrative · 3

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Additional Manufacturer Narrative · 4

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Additional Manufacturer Narrative · 5

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 5

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Additional Manufacturer Narrative · 6

    THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR AFP RESULTS IS UNK. AS STATED IN THE IFU: "USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVALUATION OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSTICS." NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 6

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED BY THE CUSTOMER ON SIX PT SAMPLES. THE CUSTOMER RUNS ALL AFP TESTS IN DUPLICATE. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED LOW DISCORDANT AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY LOK SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 127

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3
    4
    5
    6