BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 12745023 · Received November 3, 2021

    Report

    Report Number
    1000113657-2021-00695
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 3, 2021
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. 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 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 HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM METER MEMORY OF 134, 161, 119, 196 AND 202 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH RESULTS OBTAINED OF 224 MG/DL FASTING AND BACK TO BACK TEST RESULTS OF 187 AND 191 MG/DL FASTING. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-100 MG/DL AND EXPECTED PM NON-FASTING EXPECTED BLOOD GLUCOSE TEST RESULT IS 180 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED SHE HAD GONE TO THE EMERGENCY ROOM ON (B)(6) 2021 DUE TO THE RESULTS OBTAINED OF 224, 187 AND 191 MG/DL. CUSTOMER STATED SHE WAS EXPERIENCING "FEELINGS" IN HER EYES AND THAT USUALLY HAPPENS WHEN HER BLOOD GLUCOSE IS HIGH. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL HAD BEEN 171 MG/DL FASTING. CUSTOMER DID NOT RECEIVE ANY DIAGNOSIS/MEDICAL TREATMENT; CUSTOMER WAS DISCHARGED WITH NO RECOMMENDED CHANGES TO HER MEDICAL TREATMENT PLAN. 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 03/16/2022 AND TEST STRIPS WERE OPENED TWO-THREE WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 134 MG/DL DATE: (B)(6) 2021 TIME: 8:20 AM FASTING. RESULT 2: 161 MG/DL DATE: (B)(6) 2021 TIME: 10:57 PM FASTING. RESULT 3: 119 MG/DL DATE: (B)(6) 2021 TIME: 8:35 PM FASTING. RESULT 4: 196 MG/DL DATE: (B)(6) 2021 TIME: 8:01 PM UNKNOWN. RESULT 5: 202 MG/DL DATE: (B)(6) 2021 TIME: 7:23 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641297 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX AID 50CT24/CASE MG/DL MX4422S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization