BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRIX AIR

    MDR report key: 7589318 · Received June 11, 2018

    Report

    Report Number
    1000113657-2018-00640
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 23, 2018
    Report Date
    June 11, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007584
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-57-USER HAD AN INACCURATE REFERENCE: ALTERNATE METER: THE END USER IS COMPARING RESULTS OBTAINED FROM ONE OF TRIVIDIA'S BGM SYSTEM TO THE RESULTS FROM ANOTHER TRIVIDIA'S BGM SYSTEM TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    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 203, 187, 201, 200 AND 228 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-160MG/DL. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER DID STATE THAT IN APRIL SHE HAD PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 200 MG/DL FASTING. CUSTOMER STATED THAT BASED ON THIS RESULT SHE HAD ADMINISTERED ABOUT FIVE UNITS OF INSULIN. CUSTOMER STATED SHE THEN STARTED TO SHAKE BECAUSE HER BLOOD SUGAR HAD DROPPED LOW. CUSTOMER STATED SHE HAD EATEN SOME SUGAR AND HONEY TO BRING HER GLUCOSE BACK UP. CUSTOMER DID NOT SEEK ANY MEDICAL ATTENTION AT THAT TIME. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/30/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429877 METRIX AIR BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. METRIX AIR MV2741 00021292007584

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR