BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2221354 · Received August 24, 2011

    Report

    Report Number
    2517506-2011-00130
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CIC
    PMA / PMN Number
    K061792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 CALCIUM RESULT IS USER ERROR. THE PRINTOUT ERROR FLAG (BELOW ASSAY RANGE) SHOULD HAVE PRECLUDED THE REPORTING OF THE RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED CALCIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE FLAGGED RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS ADMITTED AND IV CALCIUM GLUTAMATE SOLUTION WAS ADMINISTERED. A REPEAT OF THE ORIGINAL SAMPLE WAS RUN AFTER IV ADMINISTRATION AND A HIGHER RESULT WITHIN THE NORMAL RANGE WAS OBTAINED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IV ADMINISTRATION OR THE FALSELY DEPRESSED CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA (R) CLINICAL CHEMISTRY SYSTEM CALCIUM FLEX® REAGENT CARTRIDGE CIC SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 11122BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization