BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1901711 · Received November 17, 2010

    Report

    Report Number
    1226181-2010-00147
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED TPSA RESULT WAS A MALFUNCTION OF THE R2 PROBE. THE CUSTOMER CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED TPSA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A LOWER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TPSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD XPANDPLUSHM

    Patients

    Seq Age Sex Outcome Treatment
    1