BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2478016 · Received March 5, 2012

    Report

    Report Number
    2517506-2012-00041
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT LOW TACROLIMUS RESULT IS UNKNOWN. USER ERROR, I.E. ACCEPTANCE OF A FLAGGED RESULT (PRINTED WITH A CODE THAT SHOULD PRECLUDE REPORTING), CONTRIBUTED TO THE DISCORDANT TACROLIMUS RESULT REPORTING. THE DIMENSION SYSTEM OPERATOR'S MANUAL STATES THAT IF AN ABNORMAL REACTION CODE IS OBTAINED, THE RESULT SHOULD NOT BE REPORTED. ADDITIONALLY, 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

    A DISCORDANT HIGH TACROLIMUS RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS FLAGGED WITH AN ASSAY RANGE CODE THAT SHOULD HAVE PRECLUDED REPORTING. NEVERTHELESS, THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS DISCORDANT WITH AN ALTERNATE INSTRUMENT SYSTEM. THE LOWER RESULT OF THE ALTERNATE METHOD WAS WITHIN THE THERAPEUTIC RANGE. THE TACROLIMUS DOSAGE WAS DECREASED AS A RESULT OF THE DISCORDANT HIGH TACROLIMUS RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT TACROLIMUS RESULT OR DOSAGE CHANGE.

    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 FC2284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other