BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® SYSTEM

    MDR report key: 2555268 · Received May 1, 2012

    Report

    Report Number
    2517506-2012-00070
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    August 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MKW
    PMA / PMN Number
    K062236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CYCLOSPORIN A RESULT WAS USER ERROR. THE OPERATOR DID NOT ENTER THE DILUTION FACTOR OF 3 FOR THE DILUTED SPECIMEN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED CYCLOSPORIN A RESULT WAS REPORTED ON A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND A HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CYCLOSPORIN A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® SYSTEM CYCLOSPORIN A FLEX® REAGENT CARTRIDGE MKW SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW

    Patients

    Seq Age Sex Outcome Treatment
    1