BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 8621785 · Received May 17, 2019

    Report

    Report Number
    1000113657-2019-00530
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 17, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K000000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT: #(B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18- USER HAS HIGH GLUCOSE VALUE. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED - UNABLE TO ESTABLISH CONTACT AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FREQUENT URINATION AND EXCESSIVE THIRST. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. CALLER STATES THE HOSPITAL READ 700MG/DL AND THE DIAGNOSTICS FROM MEDICAL FACILITY WAS HYPERGLYCEMIA. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415197 N/A BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. N/A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization