BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7053764 · Received November 22, 2017

    Report

    Report Number
    1000113657-2017-01996
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 22, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007447
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE HOMECARE NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 258, 141, 193, 299 AND 195 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 100 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER AS CUSTOMER WAS NOT FASTING AT TIME OF CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH ALL FASTING RESULTS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833379 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MU2457 00021292007447

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR