BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 12024669 · Received June 18, 2021

    Report

    Report Number
    1000113657-2021-00393
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 18, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 263, 255, 280 AND 259 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 250 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. DAUGHTER STATED THAT ON (B)(6) 2021 SHE HAD CALLED THE AMBULANCE, AS CUSTOMER WAS CLAMMY, "OUT OF IT" AND NOT ABLE TO ANSWER QUESTIONS WHEN ASKED. CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN TAKEN BY EMT'S WAS 750 MG/DL NON-FASTING AND CUSTOMER WAS TAKEN TO THE HOSPITAL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS TREATED WITH IV INSULIN. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021 WITH A NEW PRESCRIPTION FOR BASAGLAR. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 263 MG/DL USING TRUE METRIX AIR METER; CUSTOMER WAS SATISFIED WITH THE RESULT OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/24/2021 AND TEST STRIPS HAVE BEEN OPEN FOR ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; CUSTOMER CONFIRMED ALL RESULTS ARE AM FASTING): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920214 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MX4247S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization