BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3944538 · Received July 18, 2014

    Report

    Report Number
    1226181-2014-00374
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Removal / Correction Number
    1226181-05/21/2015-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS HAS IDENTIFIED THE FOLLOWING TWO ISSUES USING DIMENSION VISTA INTELLIGENT LAB SYSTEM SOFTWARE VERSIONS 3.6.1, 3.6.1_MU3P, AND 3.6.1SP1. THE FIRST ISSUE IS THAT SAMPLES MAY STOP PROCESSING WITHOUT NOTIFICATION. THE SECOND ISSUE, WHICH CAN ONLY OCCUR ON THE DIMENSION VISTA 1500 SYSTEM, IS UNEXPECTED RESULTS DUE TO A TIMING ISSUE THAT CAUSES A REAGENT SERVER TO TEMPORARILY LOSE SYNCHRONIZATION DURING THE AUTOMATIC REMOVAL OF REAGENT CARTRIDGES FROM REAGENT SERVER 2 TO WASTE A CONTAINER. IN THIS SCENARIO, INCORRECT REAGENT OR NO REAGENT DELIVERY MAY OCCUR. AN URGENT MEDICAL DEVICE CORRECTION (UMDC) WAS SENT TO CUSTOMERS WITHIN THE US IN (B)(6) 2015 AND AN URGENT FIELD SAFETY NOTICE (UFSN) WAS SENT TO CUSTOMERS OUTSIDE THE UNITED STATES IN (B)(6) 2015. THE UMDC AND UFSN ARE FOR THE DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM AND THE DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM AND ARE ENTITLED "INFORMATION REGARDING VISTA SOFTWARE ISSUES." THE UMDC/UFSN EXPLAIN THESE ISSUES AND PROVIDE ACTIONS CUSTOMERS CAN TAKE IF THEY EXPERIENCE THEM. SIEMENS WILL BE PROVIDING CORRECTIONS FOR THESE ISSUES IN A FUTURE VISTA SOFTWARE VERSION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, TSC DISCOVERED THAT DURING THE RUN THE CUSTOMER KEPT LOADING SAMPLES WHEN THE SYSTEM WAS NOT ALIQUOTING. TSC ADVISED THE CUSTOMER TO LOOK IN THE ERROR LOG TO RESOLVE ISSUES PRIOR TO LOADING MORE SAMPLE RACKS. THE CAUSE OF THE DELAY IN PATIENT RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR OF A DIMENSION VISTA 1500 INSTRUMENT STATED THAT THE INSTRUMENT STOPPED PROCESSING PATIENT SAMPLES. SOME OF THE PATIENT SAMPLES HAD TO BE REDRAWN, CAUSING DELAY IN DELIVERY OF PATIENT RESULTS. THE SAMPLES WERE TESTED FOR ALBUMIN (ALB), BLOOD UREA NITROGEN (BUN), CALCIUM (CA), CHLORIDE (CL) , CARBON DIOXIDE (CO2), CREATININE (CREA) , GLUCOSE (GLU), POTASSIUM (K), SODIUM (NA) , PHOSPHORUS (PHOS), MICRO ALBUMIN (MALB), AND AMMONIUM (AMM). NO RESULTS WERE GENERATED FROM THE INITIAL SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423202 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1