BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2831538 · Received November 14, 2012

    Report

    Report Number
    2517506-2012-00306
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    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 ALTI RESULT IS USER ERROR. THE ACCOUNT FAILED TO FOLLOW INSTRUCTIONS IN THE ALTI METHOD FOR CALIBRATION CALCULATION. THE SIEMENS HEALTHCARE DIAGNOSTICS INC TECHNICAL SERVICE CENTER REPRESENTATIVE DIRECTED THE CUSTOMER TO PROPER CALIBRATION CALCULATION FOR THE METHOD WHICH RESOLVED THE ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED ALANINE AMINOTRANSFERASE (ALTI) RESULTS WERE OBTAINED ON QC AND A PATIENT SAMPLE. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. A REPEAT WAS RUN AFTER CORRECTION OF A CALIBRATION ERROR AND A LOWER ALTI RESULT WAS OBTAINED AND REPORTED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED PATIENT ALTI RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM ALANINE AMINOTRANSFERASE FLEX® REAGENT CARTRIDGE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW BD3199

    Patients

    Seq Age Sex Outcome Treatment
    1