BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASSTRAK IMMUNOSUPPRESSANTS KIT

    MDR report key: 2460622 · Received December 20, 2011

    Report

    Report Number
    1218959-2011-00002
    Event Type
    Injury
    Date Received
    December 20, 2011
    Date of Event
    November 16, 2011
    Report Date
    December 8, 2011
    Manufacturer
    WATERS CORPORATION
    Product Code
    MLM
    PMA / PMN Number
    K063868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF THE LABORATORY METHOD EMPLOYED BY (B)(6) REVEALED DEVIATIONS FROM THE WATERS MASSTRACK IMMUNOSUPPRESSANTS KIT - ANALYSIS OF TACROLIMUS DIRECTIONS FOR USE (DFU) INCLUDING USE OF AN INCORRECT SOLVENT TO PREPARE A SAMPLE PRETREATMENT REAGENT. THE MASSTRACK IMMUNOSUPPRESSANTS KIT FROM THE REPORTED LOT (#4110) WAS EVALUATED ON SITE ON (B)(4) 2011 BY A WATERS SERVICE ENGINEER USING THE WATERS ACQUITY TQD MASS SPECTROMETER (B)(4). TESTING WAS PERFORMED IN ACCORDANCE WITH THE DFU INCLUDING USE OF THE CORRECT SOLVENT TO PREPARE THE SAMPLE PRETREATMENT REAGENT. A CALIBRATION SERIES INCLUDING PT SAMPLES WITH KNOWN TACROLIMUS PROFILES WAS TESTED AND THE RESULTS OF THIS TEST ALIGNED WITH THE VALUES EXPECTED BY THE CUSTOMER. THIS CUSTOMER IS CURRENTLY PERFORMING THE ASSAY PER THE DFU AND HAS NOT SEEN A RECURRENCE OF THE REPORTED ISSUE. THE COMPLAINT REMAINS OPEN AS WE CONTINUE THE INVESTIGATION TO CONFIRM CAUSATION. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A WATERS LABORATORY CUSTOMER REPORTED THAT SIXTEEN INACCURATELY HIGH TACROLIMUS VALUES WERE REPORTED TO PTS' PHYSICIANS ON (B)(6) 2011 AS A RESULT OF A THERAPEUTIC DRUG MONITORING (TDM) ASSAY RUN USING THE MASSTRAK IMMUNOSUPPRESSANTS KIT FOR ANALYSIS OF TACROLIMUS. THE LABORATORY REPEATED THE TEST AND NOTIFIED THE PHYSICIANS OF THE CORRECT RESULTS ON (B)(6) 2011. PER THE CUSTOMER, THIS INCIDENT RESULTED IN DOSE CHANGES FOR TWO PTS. THE CUSTOMER BELIEVES THE ISSUE IS DUE TO THE SAMPLE EXTRACTION (PRETREATMENT) METHOD THEY USED AND REPORTS THAT THEY DEVIATED FROM THE WATERS MASSTRAK IMMUNOSUPPRESSANTS KIT-ANALYSIS OF TACROLIMUS DIRECTIONS FOR USE (DFU) BY USING METHANOL SOLVENT RATHER THAN ACETONITRILE TO PREPARE A SAMPLE PRETREATMENT REAGENT. ALTHOUGH THE PT CONDITIONS ARE UNK, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY BASED ON THE INFO PROVIDED BY THE CUSTOMER THAT TWO DOSE CHANGES WERE MADE. PT CONDITIONS AS A RESULT OF THE DOSE CHANGE ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASSTRAK IMMUNOSUPPRESSANTS KIT TACROLIMUS TEST SYSTEM MLM WATERS CORPORATION NA 4110

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other ACQUITY TQD MASS SPECTROMETER: (B)(4)| WATERS