BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3241245 · Received July 22, 2013

    Report

    Report Number
    2517506-2013-00325
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Removal / Correction Number
    2517506-11-27-2012-018-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE EVENT OCCURRED AND THE CUSTOMER WAS SATISFIED WITH THE PERFORMANCE OF THE REAGENT. HOWEVER, THE CAUSE OF THE BIASED LOW RESULTS RELATIVE TO THE ALTERNATE METHODOLOGY WAS INVESTIGATED BY SIEMENS HEALTHCARE DIAGNOSTICS INC. SIEMENS HEALTHCARE DIAGNOSTICS INC. ISSUED AN URGENT MEDICAL DEVICE CORRECTION LETTER, 13-48, IN JULY 2013. THE LETTER STATED THAT SIEMENS HAS CONFIRMED THAT THE DIMENSION TACR FLEX REAGENT CARTRIDGE LOT BB4087 AND ITS LINKED CALIBRATOR LOT 3BD029 MAY EXHIBIT LOW PATIENT SAMPLE RECOVERY ALTHOUGH QUALITY CONTROL (QC) MATERIALS HAVE NOT EXHIBITED RECOVERY OUTSIDE OF THE EXPECTED RANGE. SIEMENS INTERNAL COMPLAINT TESTING VERSUS THE REFERENCE LC/MS METHOD CONFIRMED AN AVERAGE BIAS OF -1.6 NG/ML [-2.1 NMOL/L], ACROSS THE ASSAY RANGE. INDIVIDUAL PATIENTS, PARTICULARLY SAMPLES WITH LOWER TACR VALUES (< 5 NG/ML [6.5 NMOL/L]), MAY SHOW MORE BIAS DUE TO THE TYPICAL PRECISION OF EACH METHODOLOGY. SIEMENS OBSERVED SOME LOW PATIENT LCMS TACROLIMUS SAMPLES (< 5 NG/ML [6.5 NMOL/L]) THAT GENERATED RESULTS BELOW THE DIMENSION TACROLIMUS ASSAY RANGE (< 1.2 NG/ML [1.6 NMOL/L]). THE ISSUE IS UNDER INVESTIGATION. CUSTOMERS WERE INSTRUCTED TO DISCONTINUE USE AND IMMEDIATELY DISCARD ANY REMAINING INVENTORY OF DIMENSION TACR FLEX LOT BB4087 AND CALIBRATOR LOT 3BD029. SIEMENS IS INVESTIGATING THE ISSUE AND WILL IMPLEMENT ADDITIONAL CONTROLS TO ENSURE ACCEPTABLE BIAS PRIOR TO ANY FUTURE SHIPMENTS.

    Description of Event or Problem · 1

    BIASED LOW RESULTS WERE OBTAINED ON TACROLIMUS (TACR) PATIENT SAMPLES IN A METHOD CROSSOVER STUDY. THE REAGENT LOT WAS IN USE AND PATIENT RESULTS WERE REPORTED TO THE PHYSICIANS. THE ACCOUNT WAS SATISFIED WITH THE PERFORMANCE OF THE ASSAY. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE BIASED LOW RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE BIASED LOW TACROLIMUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340478 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS (TACR) FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC BB4087

    Patients

    Seq Age Sex Outcome Treatment
    1