BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 17969216 · Received October 19, 2023

    Report

    Report Number
    1000113657-2023-00520
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 19, 2023
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO SCHOOL NURSE DUE TO SYMPTOM(S) RELATED TO DIABETES (SLEEPY) THAT HAD OCCURRED AFTER OBTAINING HIGH RESULT OF 453 MG/DL AND ADMINISTERING INSULIN. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. 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. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER (5-YEAR-OLD DAUGHTER). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 203, 281, 215, 453, 84, 251 AND 148 MG/DL. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE <200 MG/DL AM FASTING AND 200-300 MG/DL PM FASTING. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MOTHER STATED THAT WHEN THE CUSTOMER HAD OBTAINED THE RESULT OF 453 MG/DL, SHE HAD ADMINISTERED INSULIN AS PER HER MEDICAL TREATMENT PLAN AND HAD TAKEN THE CUSTOMER TO SCHOOL. MOTHER STATED SHE RECEIVED A TELEPHONE CALL FROM THE SCHOOL NURSE WHO INFORMED HER THAT THE CUSTOMER WAS FEELING SLEEPY. MOTHER STATED THE SCHOOL NURSE HAD TESTED THE CUSTOMER'S BLOOD GLUCOSE USING THE SCHOOL'S METER AND HAD OBTAINED A RESULT OF 45 MG/DL AM NON-FASTING; MOTHER STATED THAT DUE TO THE CUSTOMER'S AGE SHE GOES TO THE SCHOOL NURSE DAILY TO TEST. MOTHER STATED THE TIMEFRAME BETWEEN THE TWO TESTS WAS AROUND 15-30 MINUTES. MOTHER STATED THE SCHOOL NURSE HAD GIVEN THE CUSTOMER GLUCOSE TABLETS AND THE CUSTOMER'S BLOOD GLUCOSE HAD RETURNED TO NORMAL LEVELS. THE LOT NUMBER OF TEST STRIPS THE CUSTOMER WAS USING AT THE TIME IS THE SAME LOT NUMBER AS THE CURRENT VIAL; CUSTOMER WAS CONCERNED WITH HIGH AND ERRATIC RESULTS USING BOTH VIALS OF LOT ZB5318S. 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 01/31/2025 AND THE CURRENT VIAL OF TEST STRIPS WAS OPENED TWO DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 203MG/DL DATE: 09/25 TIME: 7:15 AM FASTING. RESULT 2: 281MG/DL DATE: 09/24 TIME: 1:58 PM FASTING. RESULT 3: 215MG/DL DATE: 09/24 TIME: 10:47 AM NON-FASTING. RESULT 4: 453MG/DL DATE: 09/24 TIME: 9:22 AM FASTING. RESULT 5: 84MG/DL DATE: 09/22 TIME: 10:00 AM FASTING. RESULT 6: 251MG/DL DATE: 09/22 TIME: 5:49 AM FASTING. RESULT 7: 148MG/DL DATE: 09/22 TIME: 1:22 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97283 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX MJR 50CT12/CASE MG/DL ZB5318S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other