BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 8146861 · Received December 10, 2018

    Report

    Report Number
    2517506-2018-00674
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 3, 2018
    Report Date
    January 10, 2019
    Manufacturer
    SIEMENS HEATLHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2018-00674 ON 10-DEC-2018. ADDITIONAL INFORMATION (19-DEC-2018): THE INSTRUCTIONS FOR USE (IFU) FOR TACROLIMUS (TAC) STATES THAT A TAC SAMPLE MAY BE DILUTED 1:2 WITH TAC CALIBRATOR LEVEL 1 IF THE SAMPLE IS ABOVE THE ASSAY RANGE. FURTHER DILUTIONS ARE NOT RECOMMENDED FOR THIS ASSAY. ADDITIONAL INFORMATION (02-JAN-2019): SIEMENS FURTHER INVESTIGATED THE ISSUE. THE PATIENT WAS REDRAWN AND THE RESULTS WERE HIGHER THAN EXPECTED. THE CUSTOMER RAN DILUTIONS ON THE PATIENT SAMPLE AND RESULTS OF THE DILUTIONS WERE ALSO HIGHER THAN EXPECTED. SIEMENS INSTRUCTED THE CUSTOMER TO CENTRIFUGE THE SAMPLE AND TEST THE PLASMA FOR TACROLIMUS (TAC). SIEMENS REQUESTED A LIST OF THE PATIENT'S MEDICATIONS. ADDITIONAL INFORMATION (03-JAN-2019): THE ORIGINAL PATIENT SAMPLE WAS TESTED BY AN ALTERNATE METHOD AND A LOW TAC RESULT WAS OBTAINED. SIEMENS ANALYZED THE INSTRUMENT DATA AND THERE WERE NO INSTRUMENT ISSUES SUCH AS CHROME OR FOAM. REVIEW OF THE FILTER DATA PROVIDED BY THE CUSTOMER SHOWED ONE SAMPLE ID FOR THIS PATIENT WAS RUN ONCE. SIEMENS INSTRUCTED THE CUSTOMER ON TROUBLESHOOTING WHEN THERE IS A SUSPECTED INTERFERENT FOR TAC. THE INFORMATION FOR USE (IFU) FOR TAC DOES NOT RECOMMEND PERFORMING DILUTIONS BEYOND 1:2. THE CUSTOMER DID NOT PROVIDE A LIST OF THE PATIENT'S MEDICATIONS. THIS EVENT IS ISOLATED TO A SINGLE PATIENT. THE RESULTS OF THE ALTERNATE TESTING AND THE DILUTION TESTING INDICATE THIS EVENT MAY BE DUE TO NONSPECIFIC BINDING (NSB). SIEMENS ALSO FILED SUPPLEMENTAL MDR# 2517506-2018-00676_S1 AND 2517506-2018-00677_S1 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. THE INSTRUMENT FILES WERE REVIEWED AND NO INSTRUMENT ISSUES WERE NOTED. SIEMENS HAS REVIEWED THE FILTER DATA FILES PROVIDED. THE DATA DID NOT SHOW ANY INSTRUMENT ISSUES SUCH AS CHROME, FOAM, OR OTHER ISSUES. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TAC RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE. SIEMENS ALSO FILED MDR# 2517506-2018-00676, 2517506-2018-00677, 2517506-2018-00680, 2517506-2018-00681 AND 2517506-2018-00682 FOR THIS EVENT.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED TACROLIMUS (TAC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLES WERE DILUTED AND REPEATED ON AN ALTERNATE DIMENSION EXL INSTRUMENT AND TWO NEW SAMPLE DRAWS WERE ALSO TESTED ON (B)(6) 2018 AND THE RESULTS WERE DISCORDANT. THE SAMPLE WAS TESTED BY AN ALTERNATE METHOD AND THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULTS FOR THE PATIENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TAC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986703 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEATLHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1