BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 5995026 · Received October 3, 2016

    Report

    Report Number
    1226181-2016-00473
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 2, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 1226181-2016-00473 WAS FILED ON OCTOBER 3RD, 2016. ADDITIONAL INFORMATION (10/05/2016): THE CUSTOMER IS OPERATIONAL. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ENZYMATIC CREATININE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RESULTS WERE HIGH OUT OF RANGE. THE METHOD WAS RECALIBRATED WITH THE SAME REAGENT FLEX, AND QC WAS WITHIN RANGE. THE METHOD WAS RECALIBRATED TWICE WITH A NEW REAGENT FLEX, AND URINE QC LEVEL 1 FAILED. THE METHOD WAS RECALIBRATED AGAIN WITH ANOTHER REAGENT FLEX, AND ALL QC RESULTED WITHIN RANGE. PATIENT SAMPLES WERE THEN RERUN, AND A DISCREPANCY WAS NOTED. A SIEMENS HEADQUARTER SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA. THERE WAS NO INDICATION OF REAGENT DELIVERY OR FOAMING ISSUES. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED ENZYMATIC CREATININE RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING LOWER. ONLY THE RESULT OF PATIENT WITH SAMPLE ID (B)(6) WAS CORRECTED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ENZYMATIC CREATININE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646820 DIMENSION VISTA 1500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1