BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4803032 · Received May 28, 2015

    Report

    Report Number
    1226181-2015-00325
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    July 1, 2014
    Report Date
    May 11, 2015
    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
    DA
    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 MAY 2015 AND AN URGENT FIELD SAFETY NOTICE (UFSN) WAS SENT TO CUSTOMERS OUTSIDE THE UNITED STATES IN MAY 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.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ENZYMATIC CREATININE (ECREA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE AND DISCORDANT, FALSELY LOW ECREA AND FALSELY ELEVATED BILIRUBIN RESULTS WERE OBTAINED ON ANOTHER PATIENT SAMPLE TESTED ON A DIMENSION VISTA INSTRUMENT. THE DISCORDANT ECREA RESULT FOR SID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). THE DISCORDANT ECREA RESULT FOR SID (B)(6) WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND THE ECREA RESULTS WERE HIGHER FOR BOTH PATIENTS AND THE BILIRUBIN RESULT FOR SID (B)(6) WAS LOWER. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THERE WAS ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346798 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1