BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 19079814 · Received April 10, 2024

    Report

    Report Number
    1000113657-2024-00144
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 10, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 28-MAR-2024 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO REPORTED MEDICAL INTERVENTION SINCE THE LAST CALL. CUSTOMER STATED THAT ON (B)(6) 2024 HE HAD BEEN FEELING DIZZY AND HAD GONE TO THE ER. CUSTOMER STATED HE DID NOT EAT FOR SEVERAL HOURS AND HAD ONLY WATER AT THE TIME HE FELT DIZZY. CUSTOMER'S BLOOD GLUCOSE TEST RESULT AT THE ER HAD BEEN 240 MG/DL (UNDISCLOSED IF FASTING/NON-FASTING). CUSTOMER HAD BEEN GIVEN IV LIQUIDS FOR DEHYDRATION AND HAD BEEN ADVISED TO NOT GO SO LONG WITHOUT EATING. CUSTOMER DID NOT RECEIVE ANY MEDICATION AND HAD BEEN DISCHARGED THE SAME DAY. CUSTOMER WAS FEELING WELL AT THE TIME OF THE FOLLOW-UP CALL AND DID NOT REPOT ANY SYMPTOMS. CUSTOMER STATED HE HAD RECEIVED NEW SUPPLIES FROM HIS SUPPLIER AFTER THE MEDICAL INTERVENTION ON (B)(6) 2024 AND HE IS COMFORTABLE WITH THE GLUCOSE READINGS FROM THE PRODUCT.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 156, 175, 143, 163 AND 172 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 120 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, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE CUSTOMER'S TEST STRIPS ARE EXPIRED: TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/25/2024 AND TEST STRIPS WERE OPENED MORE THAN 4 MONTHS AGO ((B)(6) 2023). THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 156 MG/DL DATE: (B)(6) 2024 TIME: 11:41AM FASTING. RESULT 2: 175 MG/DL DATE: (B)(6) 2024 TIME: 11:40 AM FASTING. RESULT 3: 143 MG/DL DATE: (B)(6) 2024 TIME: 6:58 AM FASTING. RESULT 4: 163 MG/DL DATE: (B)(6) 2024 TIME: 6:57 AM FASTING. RESULT 5: 172 MG/DL DATE: (B)(6) 2024 TIME: 6:04 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407177 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL MA4539S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization