BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAG-SENSE PT/INR SYSTEM

    MDR report key: 13711859 · Received March 8, 2022

    Report

    Report Number
    MW5107987
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 8, 2022
    Manufacturer
    COAGUSENSE INC
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING TO REPORT A PRODUCT QUALITY PROBLEM. CALLER TAKES WARFARIN AND AS PART OF HER ROUTINE CARE, MONITORS HER INR LEVELS WEEKLY AT HOME USING A COAG-SENSE PT/INR SYSTEM. CALLER REPORTS THAT TEST STRIPS SHIPPED TO HER HAVE ARRIVED DAMAGED AND BENT, AND SHE HAS REACHED OUT TO THE EQUIPMENT DISTRIBUTOR (REMOTE CARDIAC SERVICES, AKA RCS) TO REPORT THIS PROBLEM. IN ADDITION, EACH PACKAGE OF SUPPLIES THAT IS SHIPPED MUST ALSO CONTAIN A BARCODE NUMBER; THIS BARCODE NUMBER IS ESSENTIAL AS IT MUST BE MANUALLY INPUT INTO HER COAG-SENSE PT/INR SYSTEM IN ORDER TO EVALUATE HER BLOOD SAMPLE. ONE OF THE PACKAGES OF SUPPLIES SHE RECEIVED WAS MISSING THIS BARCODE NUMBER, AND WITHOUT IT SHE CANNOT OPERATE HER EQUIPMENT. SHE HAS ATTEMPTED COMMUNICATION REGARDING THESE PROBLEMS WITH THE DEVICE MANUFACTURER, THE DISTRIBUTOR, AS WELL AS HER DOCTOR'S OFFICE AND FEELS LIKE EACH ENTITIY IS POINTING THE FINGER OF BLAME AT THE OTHER. SHE IS FRUSTRATED AND SO IS REPORTING TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226474 COAG-SENSE PT/INR SYSTEM TEST, TIME, PROTHROMBIN GJS COAGUSENSE INC 210292
    2226475 COAG-SENSE PT/INR SYSTEM TEST, TIME, PROTHROMBIN GJS COAGUSENSE INC 210292

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female