BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3926357 · Received July 10, 2014

    Report

    Report Number
    1226181-2014-00358
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT THE CUSTOMER SITE. PRIOR TO SERVICE, THE CUSTOMER HAD PERFORMED AN ADVANCED SYSTEM CLEAN AND REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SENSOR AND IMT TUBING. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE PERFORMED A POWER-FLUSH AND RAN QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA, WHICH INDICATED THE PRESENCE OF FIBRIN, GEL, OR CELLULAR MATERIAL IN A SAMPLE. AFTER PROCESSING THIS SAMPLE, MULTIPLE SUBSEQUENT SAMPLES RESULTED AS DISCORDANT DUE TO CONTAMINATION BY THE PREVIOUS SAMPLE. A SYSTEM CLEAN, RUN AS PART OF ROUTINE MAINTENANCE, RESOLVED THE ISSUE. IT WAS ALSO DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA AND CL RESULTS IS DUE TO SAMPLE INTEGRITY. THE CAUSE OF THE SAMPLES BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULTS OF SOME SAMPLES WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404476 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1