BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMENSION(R) CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2163891 · Received July 15, 2011

    Report

    Report Number
    2517506-2011-00117
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 22, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED TACROLIMUS RESULT IS AN INVALID CALIBRATION. USER ERROR, I.E. ACCEPTANCE OF OUTLIERS DURING CALIBRATION, CAUSED THE FALSELY DEPRESSED TACROLIMUS RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED TACROLIMUS RESULT WAS REPORTED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS LATER REPEATED WITH A NEW REAGENT LOT AND CALIBRATION ON THE SAME INSTRUMENT AND A HIGHER RESULT WAS OBTAINED. A HIGHER RESULT WAS OBTAINED WITH AN ALTERNATE METHODOLOGY. PATIENT DRUG DOSAGE WAS REGULATED ON THE BASIS OF THE DEPRESSED TACROLIMUS RESULT. THERE WAS A REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED TACROLIMUS RESULT. THE CUSTOMER REPORTED PATIENT CONDITION DETERIORATION INCLUDING DEVELOPMENT OF ENCEPHALOPATHY, LOST KIDNEY, DIALYSIS AND VOMITING OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TACR) FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC FA1284

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention