BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1200

    MDR report key: 1940963 · Received December 17, 2010

    Report

    Report Number
    2432235-2010-00189
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 22, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED ALL MECHANICAL PROBE AND MIXER ALIGNMENTS, CHECKED AND CLEANED THE WATER SUPPLY PUMP FILTER AND ADJUSTED THE WATER SUPPLY PUMP PRESSURE. 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 EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CALCIUM_2 RESULTS WERE OBTAINED FOR THREE PTS ON AN ADVIA 1200. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND CONFIRMED ON THE SAME SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT CALCIUM_2 RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED ALL MECHANICAL PROBE AND MIXER ALIGNMENTS, CHECKED AND CLEANED THE WATER SUPPLY PUMP FILTER AND ADJUSTED THE WATER SUPPLY PUMP PRESSURE. 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 EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT CALCIUM_2 RESULTS WERE OBTAINED FOR THREE PTS ON AN ADVIA 1200. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND CONFIRMED ON THE SAME SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT CALCIUM_2 RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CHECKED ALL MECHANICAL PROBE AND MIXER ALIGNMENTS, CHECKED AND CLEANED THE WATER SUPPLY PUMP FILTER AND ADJUSTED THE WATER SUPPLY PUMP PRESSURE. 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 EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCORDANT CALCIUM_2 RESULTS WERE OBTAINED FOR THREE PTS ON AN ADVIA 1200. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND CONFIRMED ON THE SAME SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT CALCIUM_2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1200 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3