BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2823105 · Received November 7, 2012

    Report

    Report Number
    2517506-2012-00299
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE TACROLIMUS RESULTS IS UNKNOWN. NOTE: THE TACROLIMUS FLEX(R) REAGENT CARTRIDGE INSTRUCTIONS FOR USE STATES; "A TEST RESULT THAT IS INCONSISTENT WITH THE CLINICAL PICTURE AND PATIENT HISTORY SHOULD BE INTERPRETED WITH CAUTION. CONFIRMATION OF UNEXPECTED OR ATYPICAL RESULTS BY AN ALTERNATIVE METHODOLOGY IS RECOMMENDED PRIOR TO ANY ADJUSTMENTS IN TACROLIMUS DOSAGE." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    IMPRECISE RESULTS WERE OBTAINED ON A TACROLIMUS (TACR) PATIENT SAMPLE. THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS RE-RUN AND A LOWER 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 IMPRECISE TACROLIMUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TACR) FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC FA3064

    Patients

    Seq Age Sex Outcome Treatment
    1