BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 14274228 · Received May 4, 2022

    Report

    Report Number
    1000113657-2022-00254
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 2, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT BEING SUBMITTED DUE TO CUSTOMER STATING SHE ADMINISTERED TOO MUCH INSULIN CAUSING HER TO "BOTTOM OUT." METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. 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 · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 241, 160 AND 147 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS 103 MG/DL, EXPECTED TWO HOUR POST LUNCH/DINNER EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 150-165 MG/DL AND EXPECTED BEDTIME BLOOD GLUCOSE TEST RESULT RANGE IS 130-140 MG/DL (FASTING/NON-FASTING UNDISCLOSED). CUSTOMER STATED THAT THE NIGHT BEFORE SHE HAD TAKEN TO MUCH INSULIN AND HAD "BOTTOMED OUT." CUSTOMER STATED THAT SHE KNOWS WHAT TO DO WHEN HER BLOOD GLUCOSE IS TOO LOW AND HAD DRANK ORANGE JUICE. AT THE TIME OF THE CALL, 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 DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 08/22/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 58 MG/DL): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184840 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZY4665S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other