BEUDAMED
    FDA Adverse Event Summary report: N

    MICROMEDEX

    MDR report key: 8206264 · Received December 28, 2018

    Report

    Report Number
    MW5082679
    Date Received
    December 28, 2018
    Manufacturer
    IBM CORPORATION INC./TRUVEN HEALTH ANALYTICS
    Product Code
    OUG
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) PATIENT WEIGHING (B)(6), SERUM CR OF 1.0 RESTARTED IN THE HOSPITAL ON PATIENT¿S HOME DOSE OF APIXABAN 2.5MG PO TWICE DAILY FOR NON-VALVULAR AFIB. THE PHARMACIST VERIFYING THE ORDER DISCUSSED WITH THE HOSPITALIST AFTER REVIEWING RENAL DOSING IN MICROMEDEX. THE DOSE WAS INCREASED TO 5MG PO TWICE DAILY. THE PATIENT RECEIVED ONE DOSE OF APIXABAN 5MG, AND THE CLINICAL PHARMACIST SWITCHED THE DOSING BACK TO 2.5MG PO TWICE DAILY. MICROMEDEX IS UNCLEAR IN THEIR LISTING FOR ADJUSTING DOSE. IF A PRACTITIONER WERE TO NOT READ ALL OF THE ADJUSTMENTS LISTED, THEY WOULD REPEAT THE ABOVE ERROR. UPTODATE AND THE PACKAGE INSERT BOTH HAVE SIMPLE AND EASY TO FOLLOW DOSE ADJUSTMENTS THAT SHOULD BE MIRRORED IN THE MICROMEDEX MONOGRAPH. I HAVE TRIED 3 TIMES TO DISCUSS W/ MICROMEDEX, EACH TIME ON TERMINAL HOLD FOR SOMEONE TO PICK UP THE PHONE. THEY DO NOT HAVE AN EMAIL SUBMISSION PROCESS ANYMORE (THAT I CAN FIND). I WILL CONTINUE TO TRY TO DISCUSS W/ MICROMEDEX. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044040 MICROMEDEX MEDICAL DEVICE DATA SYSTEM OUG IBM CORPORATION INC./TRUVEN HEALTH ANALYTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 65-84