BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 4297869 · Received December 4, 2014

    Report

    Report Number
    1219913-2014-00292
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE CUSTOMER HAD REPORTED EXCESSIVE DRIPPING ON THE RING BY THE SAMPLE AND ANCILLARY PROBE. THE FSE REPLACED THE SAMPLE PROBE, SAMPLE SYRINGE, AND THE TUBE TO THE PROBE. THE PROBE POSITIONS WERE CALIBRATED. THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS COULD POSSIBLY BE ATTRIBUTED TO EXCESSIVE DRIPPING ON THE INCUBATION RING DISPENSE PORT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS." THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "SAMPLES WITH A CALCULATED VALUE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE ARE CONSIDERED REACTIVE FOR IGG ANTIBODIES TO (B)(6). IT IS RECOMMENDED THAT THE SAMPLE BE REPEATED IN DUPLICATE. IF 2 OF THE 3 SAMPLE RESULTS ARE LESS THAN 0.80 INDEX VALUE, THE SAMPLE IS CONSIDERED NONREACTIVE. IF 2 OF THE 3 SAMPLE RESULTS ARE GREATER THAN OR EQUAL TO 1.00 INDEX VALUE, THE SAMPLE IS CONSIDERED REACTIVE AND SUPPLEMENTAL TESTING OF THE SAMPLE IS RECOMMENDED. IF 2 OF THE 3 SAMPLE RESULTS ARE GREATER THAN OR EQUAL TO 0.80 INDEX VALUE AND LESS THAN 1.00 INDEX VALUE, SUPPLEMENTAL TESTING OF THE SAMPLE IS RECOMMENDED." INSTRUMENT INFORMATION: BRAND NAME: ADVIA CENTAUR XP, COMMON DEVICE NAME: IMMUNOASSAY ANALYZER, PRODUCT CODE: (B)(4), MODEL #: ADVIA CENTAUR XP, SERIAL #: (B)(4), 510K #: K971418.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP (B)(4) RESULTS WERE OBTAINED ON SAMPLES FROM THREE DIFFERENT PATIENTS. THE INITIAL RESULTS WERE (B)(6) AND UPON REPEAT WERE (B)(6). IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(4) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783149 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 249

    Patients

    Seq Age Sex Outcome Treatment
    1