BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1800

    MDR report key: 1830227 · Received September 7, 2010

    Report

    Report Number
    2432235-2010-00115
    Event Type
    Other
    Date Received
    September 7, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THE INSTRUMENT WAS FUNCTIONING PROPERLY AND THE PROBLEM WAS AN ISOLATED EVENT CAUSED BY EITHER A SAMPLE RELATED PROBLEM OR A ONE TIME MECHANICAL FAILURE. THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CORRECTED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT CREATINE KINASE (CK) RESULT WAS OBTAINED ON AN ADVIA 1800 FOR 1 PATIENT. THE RESULT WAS REPORTED TO THE HEALTHCARE PROVIDER. THE PATIENT SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CREATINE KINASE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1