BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TACROLIMUS

    MDR report key: 23778185 · Received December 11, 2025

    Report

    Report Number
    1823260-2025-05052
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    August 21, 2025
    Report Date
    January 8, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MLM
    UDI-DI
    04015630940271
    PMA / PMN Number
    K173857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELD D DEVICE IDENTIFICATION SECTION D4 LOT NO WAS UPDATED. THE CUSTOMER CLARIFIED THAT THE INFORMATION PROVIDED FOR PATIENT 2 IS A PARALLEL CONTROL SAMPLE. ADDITIONAL RESULTS WERE PROVIDED FOR PATIENT 1. THE ANALYZER USED FOR THE RESULTS WAS NOT PROVIDED. ON (B)(6) 2025, A SAMPLE DRAWN FROM THE FEMORAL VEIN HAD A RESULT OF 7.7 NG/ML. THE PATIENT WAS REPORTED TO BE IN ICU DURING THIS TIME. ON (B)(6) 2025, A SAMPLE DRAWN FROM THE LINE USED FOR MEDICATION AND PARENTERAL NUTRITION HAD A RESULT OF 27.9 NG/ML. ON (B)(6) 2025, THE RESULT FROM A NEW SAMPLE FROM THE LINE USED FOR MEDICATION AND PARENTERAL NUTRITION WAS 28.5 NG/ML. ON (B)(6) 2025, THE RESULT FROM A NEW SAMPLE FROM THE LINE USED FOR MEDICATION AND PARENTERAL NUTRITION WAS 41.5 NG/ML. ON (B)(6) 2025 A SAMPLE WAS DRAWN FROM THE FEMORAL VEIN AND ANALYZED BY ELECSYS TACROLIMUS WITH A RESULT OF 6.1 NG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2025 WITH THE MASS SPECTROMETRY ANALYZER, WITH A RESULT OF 6.4 NG/ML. IT WAS ASKED, BUT NOT SPECIFIED WHETHER THIS SAMPLE IS FROM EITHER OF THE ALREADY REPORTED PATIENTS. THE INVESTIGATION DETERMINED THAT THE SAMPLE DRAWN FROM THE CENTRAL LINE WAS NOT ADEQUATE. ALSO, THE DIFFERENCE BETWEEN THE ELECSYS TACROLIMUS AND THE ASSAY USED WITH THE MASS SPECTROMETRY ANALYZER IS THE SAMPLE FROM THE CENTRAL LINE AS WELL. NO ADDITIONAL ROOT CAUSE WAS FOUND.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE CUSTOMER REPORTED THAT THE QC IS PASSING. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TACROLIMUS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT COLLECTED FROM A MEDICATION LINE THAT THE PATIENT RECEIVES PARENTERAL NUTRITION WAS 32.5 NG/ML WITH A MASS SPECTROMETRY ANALYZER. THE RESULT WITH THE E801 WAS 23 NG/ML. A SECOND RESULT AFTER A DILUTION OF 1:2 WAS 11.7 NG/ML. ANOTHER SAMPLE WAS COLLECTED FROM THE DIALYSIS CATHETER WITH THE FOLLOWING RESULTS. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 5.8 NG/ML. THE RESULT WITH THE E801 WAS 6.23 NG/ML. ON (B)(6) 2025, A SAMPLE WAS COLLECTED FROM THE DIALYSIS CATHETER. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 6.7 NG/ML. THE RESULT WITH THE E801 WAS 6.14 NG/ML. ON (B)(6) 2025, A SAMPLE WAS COLLECTED FROM THE MEDICATION LINE WITHOUT PARENTERAL NUTRITION. THE RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 23.9 NG/ML. THE RESULT WITH THE E801 WAS 16.3 NG/ML. PATIENT 2'S INITIAL RESULT WITH A MASS SPECTROMETRY ANALYZER WAS 3.4 NG/ML. THE RESULT WITH THE E801 WAS 4.65 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718106 ELECSYS TACROLIMUS TACROLIMUS IMMUNOASSAY MLM ROCHE DIAGNOSTICS 834814 04015630940271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown