BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2041893 · Received April 6, 2011

    Report

    Report Number
    1226181-2011-00033
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JFP
    PMA / PMN Number
    K051089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CALCIUM RESULT WAS ALIQUOTTER PROBE MAINTENANCE ISSUES. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND PERFORMED MAINTENANCE PROCEDURES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CALCIUM RESULT WAS UNKNOWN. AN INSUFFICIENT SAMPLE IS SUSPECTED. A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. NO MALFUNCTIONS WERE DETECTED. THE FSE PERFORMED MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. SEVERAL OTHER ANALYTES ON THE SAME SAMPLE WERE DEPRESSED. THE RESULTS WERE REPORTED TO THE PHYSICIAN. A NEW (REDRAW) SAMPLE WAS RUN. A HIGHER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED FOR THE CALCIUM AND REPORTED. OTHER ANALYTES WERE NOT REPEATED. NO OTHER PATIENT SAMPLES WERE IMPACTED. THE PATIENT RECEIVED A IV INFUSION BASED ON THE ORIGINAL CALCIUM RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. A NEW (REDRAW) SAMPLE WAS RUN. A HIGHER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED AND REPORTED. THE PATIENT RECEIVED A IV INFUSION BASED ON THE ORIGINAL CALCIUM RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JFP SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1