BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 17700558 · Received September 7, 2023

    Report

    Report Number
    1000113657-2023-00456
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 7, 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
    FL, 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 CONTACTING DOCTOR DUE TO METER RESULTS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL (B)(6) 2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, ABLE TO CONTACT CUSTOMER WHO STATED THEY ARE COMFORTABLE WITH THE READINGS FROM THE REPLACEMENT PRODUCTS.

    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 193, 237, 187, 217 AND 288 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-140 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160-180 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE HIGH RESULTS HE HAD GONE TO HIS DOCTOR THAT DAY. CUSTOMER HAD OBTAINED THE RESULT OF 193 MG/DL AND 30 MINUTES LATER AT THE DOCTOR'S OFFICE HIS BLOOD GLUCOSE HAD BEEN 117 MG/DL FASTING. CUSTOMER WAS ADVISED TO CONTACT MANUFACTURER FOR A REPLACEMENT METER. 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2023 AND OPEN VIAL DATE IS 2 MONTHS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 193 MG/DL, DATE: 08-18, TIME: 07:35 AM, FASTING. RESULT 2: 237 MG/DL, DATE: 08-16, TIME: 05:05 PM, NON-FASTING. RESULT 3: 187 MG/DL, DATE: 08-16, TIME: 05:05 PM, NON-FASTING. RESULT 4: 217 MG/DL, DATE: 08-16, TIME: 05:03 PM, NON-FASTING. RESULT 5: 288 MG/DL, DATE: 08-16, TIME: 10:40 AM , FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201809 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZA4756S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other