BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2221356 · Received August 24, 2011

    Report

    Report Number
    2517506-2011-00131
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CIC
    PMA / PMN Number
    K061792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 UNKNOWN. 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 RESULT WAS REPORTED TO THE PRIMARY PHYSICIAN WHO REFERRED THE PATIENT TO A RENAL SPECIALIST. THE SPECIALIST QUESTIONED THE ORIGINAL RESULT. A NEW SAMPLE WAS RUN AND A HIGHER RESULT (WITHIN NORMAL RANGE) WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED CALCIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM CALCIUM FLEX® REAGENT CARTRIDGE CIC SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB2069

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR