BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15393211 · Received September 9, 2022

    Report

    Report Number
    1000113657-2022-00484
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 15, 2022
    Report Date
    October 4, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 18-AUG-2022 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WAS STILL FEELING THE SAME. NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 25-AUG-2022 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN. CUSTOMER WAS NOT CURRENTLY EXPERIENCING ANY DIABETIC SYMPTOMS AND NO MEDICAL INTERVENTION SINCE THE LAST CALL WAS REPORTED.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 04-OCT-2022: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. 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-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.

    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 126, 170, 203, 134 AND 168 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-120 MG/DL AND EXPECTED BLOOD GLUCOSE TEST RESULT 2 HOURS POST MEAL IS 130 MG/DL. THE CUSTOMER WAS FEELING SHAKY AND HAD A HEADACHE; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 127 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/14/2023 AND THE TEST STRIPS WERE OPENED TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 126 MG/DL, DATE: (B)(6) 2022, TIME: 4:24 PM, FASTING. RESULT 2: 170 MG/DL, DATE: (B)(6) 2022, TIME: 1:31 PM, 2 HRS. AFTER MEAL . RESULT 3: 203 MG/DL, DATE: (B)(6) 2022, TIME: 8:15 AM, FASTING. RESULT 4: 134 MG/DL, DATE: (B)(6) 2022, TIME: 5:56 AM, FASTING. RESULT 5: 168 MG/DL, DATE: (B)(6) 2022, TIME: 11:31 PM, 2 HRS. AFTER MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138732 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, HEALTHMART TMX50CT MG/DL MM MY4489S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown