BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2872768 · Received December 13, 2012

    Report

    Report Number
    1226181-2012-00154
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED AND TESTED THE SYSTEM. NO VISUAL ANOMALIES WERE IDENTIFIED. THE FSE PERFORMED AN INITIAL PRECISION TEST USING 6 SAMPLE CUPS; THE RESULTS WERE CONSISTENT AND THE STANDARD DEVIATION WAS WITHIN RANGE. THE FSE THEN PERFORMED A PRECISION TEST USING POOLED SERUM AND THE CUSTOMERS CHEMISTRY 8 PANEL; ALL RESULTS WERE CONSISTENT AND WITHIN STANDARD DEVIATION. THE FSE PERFORMED A PRECISION TEST OF THE SAME POOLED SERUM AND THE CUSTOMERS' COMPREHENSIVE METABOLIC PANEL (CMP); ALL RESULTS WERE CONSISTENT, HOWEVER ONE POTASSIUM RESULT WAS ABOVE RANGE. THE FSE THEN RAN THE SAME CMP PANEL TEST USING A DIFFERENT POOLED SERUM SAMPLE AND ALL THE TEST RESULTS WERE CONSISTENT WITH THE STANDARD DEVIATION WITHIN RANGE. ACCORDINGLY; THE CAUSE OF THIS EVENT IS RELATED TO PRE-ANALYTICAL SAMPLE HANDLING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO SIEMENS HEALTHCARE DIAGNOSTICS THAT DISCORDANT SODIUM (NA) AND POTASSIUM (K) RESULTS WERE GENERATED BY THE DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER. THREE OUT OF FOUR INITIAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ATTENDING PHYSICIAN(S) QUESTIONED THE VALIDITY OF THE RESULTS. PATIENT RESULT #1: INITIAL RESULT WAS NOTED AND NOT RELEASED FROM THE LABORATORY. A CORRECTED RESULT WAS ISSUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. PATIENT RESULT #2: PATIENT WAS ADMITTED TO THE HOSPITAL HOWEVER, NO FURTHER RETESTING WAS PERFORMED FOR THIS PATIENT. PATIENT RESULT #3: PATIENT WAS ADMITTED TO THE HOSPITAL AND A SAMPLE REDRAWN AND TESTED THE FOLLOWING DAY. PATIENT RESULT #4: PATIENT HAD A SAMPLE REDRAWN WHILE STILL IN THE EMERGENCY ROOM FOR UNSPECIFIED TREATMENT. THE RETESTED SAMPLE RESULTS WERE CORRECTED AND REPORTED TO THE PHYSICIAN (S). THERE ARE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND THERE WERE NO CHANGES TO ANY OF THE PATIENTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA 1500 IMMUNOASSAY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1