BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAG-SENSE

    MDR report key: 9928115 · Received April 6, 2020

    Report

    Report Number
    9928115
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 31, 2020
    Manufacturer
    COAGUSENSE INC.
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME INTO THE OFFICE FOR HER PROTIME. IT WAS 1.3. SPOKE TO PHYSICIAN REGARDING THE PROTIME RESULT AND PHYSICIAN BELIEVED IT WAS WRONG AND SENT THE PATIENT TO A LAB TO HAVE BLOOD WORK DRAWN TO RECHECK THE PROTIME. PATIENT WENT TO AN OFFSITE LABORATORY. THE PROTIME RESULTS WERE 2.73. PHYSICIAN WENT BY THE OFFSITE LAB RESULTS. OFFSITE LAB DOES HAVE A DIFFERENT METHOD TO PROCESS THE PROTIMES. IT WAS REPORTED TO OUR CLINICAL COORDINATOR. WE CHECKED THE CONTROLS AND THEY WERE WITHIN RANGE, ARE USING THE CORRECT LANCETS TO STICK THE PATIENT'S FINGER AND MAKING SURE THE PATIENT'S FINGER IS DRY AFTER WIPING IT WITH AN ALCOHOL PAD BEFORE STICKING THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391260 COAG-SENSE TEST, TIME, PROTHROMBIN GJS COAGUSENSE INC. 100107

    Patients

    Seq Age Sex Outcome Treatment
    1