BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1650

    MDR report key: 2173070 · Received July 23, 2011

    Report

    Report Number
    2432235-2011-00104
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED ALL PROBE ALIGNMENTS, REPOSITIONED REAGENT PROBE ONE, TESTED AND ADJUSTED MIXER TWO POSITION AND REPLACED A BENT ROD. THE FSE FOUND AIR BUBBLES IN THE SAMPLE PROBE WASH PUMP (SCP) AND CLEANED A CHECK VALVE. THE FSE PRIMED THE SYSTEM, RAN A CV CHECK AND TESTED FUNCTIONALITY. THE CAUSE OF THE DISCORDANT CREATININE_2 RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA 1650 CREATININE_2 RESULT WAS OBTAINED ON ONE PATIENT SAMPLE AND THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. UPON RETEST ON AN ALTERNATE INSTRUMENT, THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREATININE_2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY ANALAYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1650 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1