BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3151492 · Received June 7, 2013

    Report

    Report Number
    2517506-2013-00262
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    MLM
    PMA / PMN Number
    K060502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE LIKELY CAUSE FOR THE FALSELY ELEVATED TACROLIMUS RESULTS IS HETEROPHILIC ANTIBODY BINDING. THE PATTERN OF RESULTS REMAINING ELEVATED AFTER THE SUSPENSION OF TACR TREATMENT IS HIGHLY SUPPORTIVE OF NON-SPECIFIC BINDING ANTIBODIES IN THE PATIENT SAMPLES. THE IFU FOR THE TACROLIMUS FLEX REAGENT CARTRIDGE CONTAINS THE FOLLOWING INFORMATION: "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. ANTIBODIES TO SS-GALACTOSIDASE CAN BE ENCOUNTERED IN SAMPLES AS A CONSEQUENCE OF BACTERIAL INFECTION AND MAY PRODUCE FALSELY ELEVATED RESULTS WHICH MAY NOT BE CONSISTENT WITH CLINICAL EVALUATION. THE ASSAY HAS BEEN DESIGNED TO MINIMIZE INTERFERENCE FROM ANTIBODIES TO SS-GALACTOSIDASE. IN VERY RARE INSTANCES, IMMUNOASSAYS MAY PRODUCE FALSELY ELEVATED OR DECREASED RESULTS DUE TO OTHER PATIENT-SPECIFIC INTERFERENTS. COMPLETE ELIMINATION OF THIS INTERFERENCE FROM ALL PATIENT SPECIMENS CANNOT BE GUARANTEED. 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." SIEMENS REQUESTED SAMPLES FROM THE LABORATORY FOR CONFIRMATION IN SIEMENS LABORATORIES OF THE NON-SPECIFIC BINDING/HETEROPHILIC ANTIBODIES. SIEMENS WAS TOLD THAT THERE WAS INSUFFICIENT VOLUME OF THE INFANT SAMPLES TO PROVIDE FOR INVESTIGATIONS.

    Description of Event or Problem · 1

    DISCORDANT ELEVATED TACROLIMUS (TACR) RESULTS WERE OBTAINED ON A SERIES OF SAMPLES FROM A LIVER TRANSPLANT PATIENT OVER SEVERAL DAYS. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE LATER RESULTS IN THE SERIES. THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT (ALTERNATE METHODOLOGY) AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS CHANGED ON THE BASIS OF THE FIRST PATIENT SAMPLE RESULTS. THE PHYSICIAN SUSPENDED THE TACROLIMUS TREATMENT ON THE BASIS OF THE INITIAL HIGH RESULTS. THERE WAS A REPORT THAT THE PATIENT BEGAN SHOWING SYMPTOMS A FEW DAYS LATER AND HAD LABORATORY INDICATORS OF MODERATE LIVER TRANSPLANT REJECTION AFTER THE TREATMENT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252780 DIMENSION® CLINICAL CHEMISTRY SYSTEM TACROLIMUS FLEX® REAGENT CARTRIDGE MLM SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW FB3267

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other