BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRION

    MDR report key: 13666400 · Received March 4, 2022

    Report

    Report Number
    13666400
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 15, 2022
    Report Date
    February 18, 2022
    Manufacturer
    MICRO ESSENTIAL LABORATORY, INC.
    Product Code
    LNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS TO RECEIVE HIGH-DOSE METHOTREXATE ALONG WITH TESTING URINE ALL SHIFT. THE POCT (POINT-OF-CARE TESTING) TESTING STRIPS WERE RESULTING WITH PH RANGES OF 6.5 TO 7.0 SODIUM BICARB RATE OF INFUSION WAS INCREASED WITH NO CHANGE IN PH LEVELS. A UA WAS SENT TO THE HOSPITAL LABORATORY, AND THE PH RESULT WAS 9.0 X 2. HERE IS A BREAKDOWN OF THE DISCREPANT URINE PH TESTING RESULTS OF THE POCT STRIPS USED VERSUS WHAT THE HOSPITAL LABORATORY RESULTS WERE: DATE TIME: 1627, PH POCT: 6.5 POCT, VS TIME: 1702, LAB (L) RUN: 9 L; DATE TIME: 1703, PH POCT: 6.5 POCT, VS TIME: 1810, LAB (L) RUN: 9 L; DATE TIME: 1827, PH POCT: 7 POCT, VS TIME: 0010, LAB (L) RUN: 9 L; DATE TIME: 0847, PH POCT: 8 POCT, VS TIME: 0845 LAB (L) RUN: 9 L; DATE TIME:1048, PH POCT: 8 POCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705940 HYDRION PAPER, OBSTETRIC PH LNW MICRO ESSENTIAL LABORATORY, INC. 205820V

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA Male