BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 6041904 · Received October 19, 2016

    Report

    Report Number
    1000113657-2016-01743
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 19, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER TEST STRIPS HAD A POOR STORAGE(BATHROOM).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 195 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-170 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. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2017 AND OPEN VIAL DATE IS LESS THAN 30 DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:195 MD/DL. CUSTOMER STATES STORES SUPPLIES IN THE BATHROOM; INSTRUCTED CUSTOMER ON PROPER STORAGE TECHNIQUE AND TO KEEP SUPPLIES AWAY FROM AREAS WITH HIGH HUMIDITY SUCH AS THE KITCHEN OR BATHROOM. CUSTOMER INSISTS THE STORAGE OF SUPPLIES IN THE BATHROOM IS NOT AN ISSUE AND REFUSES TO MOVE SUPPLIES TO ANOTHER AREA WITHOUT HIGH AMOUNTS OF HUMIDITY. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN DIET, EXERCISE, OR MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692344 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MT1824

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY