BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2833437 · Received November 15, 2012

    Report

    Report Number
    2517506-2012-00303
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CIC
    PMA / PMN Number
    K061792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 SAMPLE INTEGRITY. THE SIEMENS HEALTHCARE DIAGNOSTICS TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO PERFORM ROUTINE MAINTENANCE PROCEDURES TO ADDRESS THE ISSUE. 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 QC AND A PATIENT SAMPLE. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO THE PHYSICIAN. A REPEAT WAS RUN AND A HIGHER CALCIUM RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED PATIENT CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CALCIUM FLEX® REAGENT CARTRIDGE CIC SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 12185AA

    Patients

    Seq Age Sex Outcome Treatment
    1