BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 4223778 · Received November 4, 2014

    Report

    Report Number
    1226181-2014-00559
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO SIEMENS CUSTOMER CARE CENTER (CCC) THAT RERUN OF ORIGINAL TUBE FOR ONE PATIENT SAMPLE WAS IN NORMAL RANGE AND DID NOT CORRELATE WITH THE INITIAL FALSELY LOW RESULT. THE INSTRUMENT DATA WAS REVIEWED AND INDICATED A SAMPLE INTEGRITY OR SAMPLE HANDLING ISSUE. QUALITY CONTROLS WERE RUN BY CUSTOMER AND WITHIN RANGE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW ALBUMIN RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE FALSELY LOW RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM AND CHANGED MEDICATION FOR ALL THREE PATIENTS. THE SAMPLES WERE THEN REPEATED ON THE SAME INSTRUMENT AND RESULTED HIGHER THAN THE INITIAL RESULTS. THE SAMPLE FOR ONE PATIENT (B)(6) WAS RERUN FROM ORIGINAL TUBE ON TWO DIMENSION VISTA INSTRUMENTS, WHICH ALSO RESULTED HIGHER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CORRECTED RESULTS FOR ALL THREE PATIENTS WERE IN NORMAL RANGE AND PROMPTED A REVIEW WITH RE-ORDER OF MEDICATIONS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ALBUMIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705672 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1