BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3951455 · Received July 22, 2014

    Report

    Report Number
    1226181-2014-00393
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. THE HSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THERE WAS NO EVIDENCE OF REAGENT CARRYOVER OR SYSTEM FOAMING. THE HSC REVIEWED THE ALIQUOT PROBE AND DRAIN CONDITION DATA FOR EVIDENCE OF GEL OR CELLULAR DEBRIS. THE CAUSE OF THE DISCORDANT ENZYMATIC CREATININE RESULT IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN QUALITY CONTROLS AND REPEATED THE SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ENZYMATIC CREATININE RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ENZYMATIC CREATININE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429037 DIMENSION VISTA 1500 CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1