BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 4233070 · Received November 6, 2014

    Report

    Report Number
    1226181-2014-00568
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. DURING EVALUATION OF THE INSTRUMENT, THE CSE OBSERVED CRUSTY RESIDUE ON THE ALIQUOT PROBE HOUSING. THE CSE REPLACED AND AUTO-ALIGNED THE ALIQUOT PROBE, SAMPLE PROBE 1, AND REAGENT PROBE 2 AND CLEANED DRAINS. THE CSE ALSO RAN A QUICK CHECK, WHICH PASSED, AND QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. THE CAUSE OF THE DISCORDANT RESULTS ON TWO PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES TESTED FOR MULTIPLE METHODS ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS FOR THE FIRST PATIENT (B)(6) WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND THE REPEAT RESULTS WERE ISSUED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND THE RESULTS MATCHED THE REPEAT RESULTS FROM THE ORIGINAL INSTRUMENT AND ALSO ALIGNED WITH RESULTS FROM TWO SAMPLES DRAWN FROM THE PATIENT LATER IN THE DAY. THE SECOND PATIENT SAMPLE (B)(6) WAS REPEATED ON THE SAME INSTRUMENT AND A DIMENSION EXL INSTRUMENT AND ALL REPEAT RESULTS MATCHED. IT IS UNKNOWN IF THE DISCORDANT OR REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715434 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1