BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3163449 · Received June 11, 2013

    Report

    Report Number
    2432235-2013-00209
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE PINCH VALVE FOR ASPIRATE PROBE 2 WAS INTERMITTENTLY WORKING. THE FSE REPLACED THE PINCH VALVE AND VERIFIED THE INSTRUMENT FUNCTIONALITY. THE CAUSE OF THE DISCORDANT, FALSE NEGATIVE HCV RESULT WAS A MALFUNCTION OF THE PINCH VALVE FOR ASPIRATE PROBE 2. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, (B)(6) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED (B)(6), WHICH MATCHED THE PATIENT HISTORY. IT IS UNKNOWN IF THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263770 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1