BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARUS 40

    MDR report key: 7902420 · Received September 24, 2018

    Report

    Report Number
    1000127185-2018-90001
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Manufacturer
    TZ MEDICAL INC
    Product Code
    DSI
    UDI-DI
    00081133101153
    PMA / PMN Number
    K102507
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM INTERVIEWS WITH (B)(6) - PATIENT. (B)(6) WAS TRAVELING AND DID NOT HAVE TIME TO AND DID NOT WANT TO CHARGE DEVICE. DEVICE USES A CELLULAR TECHNOLOGY TO UP LOAD DATA TO SERVER. DEVICE IS ESSENTIALLY A CELLULAR PHONE AND JUST LIKE A CELLULAR PHONE WHEN YOU ARE IN A WEEK CELLULAR ZONE AND ARE ATTEMPTING TO UPLOAD 100% OF THE DATA (SETTING SET BY TEST FACILITY) THE BATTERY DRAINS AND RECHARGING IS NECESSARY. (B)(6) WAS ABUSIVE ON THE PHONE AND WAS NOT INTERESTED IN A CONVERSATION REGARDING THE DEVICE OR ABOUT IMPROVED USE SCENARIOS. I WAS ABLE TO CONFIRM THAT SHE HAD NOT BEEN HURT IN ANY WAY AND THAT NO PHYSICIAN INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) WAS USING EVENT MONITOR. (B)(6) WAS TRAVELING DURING THE USE OF THE MONITOR. THE MONITOR REQUIRED CHARGING DAILY BECAUSE (B)(6) MONITOR WAS IN FULL UPLOAD MODE AND (B)(6) DID NOT HAVE CONSISTENT CELLULAR SERVICE AS SHE WAS DRIVING. (B)(6) FELT THAT IT WAS UNREASONABLE TO HAVE TO CHARGE THE DEVICE DAILY AND WAS VERY UPSET THAT SHE NEEDED TO. (B)(6) CONFIRMED THAT SHE WAS NOT HURT IN ANYWAY AND THAT SHE DID NOT NEED TO SEEK MEDICAL ATTENTION AS A RESULT OF USING THE DEVICE. (B)(6) WAS THE PATIENT AND NOT THE MEDICAL PROFESSIONAL OR MONITORING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744896 CLARUS 40 CLARUS MCT DSI TZ MEDICAL INC H3R-0133 00081133101153

    Patients

    Seq Age Sex Outcome Treatment
    1