BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9849598 · Received March 18, 2020

    Report

    Report Number
    1000113657-2020-00160
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    February 20, 2020
    Report Date
    March 18, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: 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 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 76 AND 102 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH HIGH BLOOD GLUCOSE TEST RESULTS OBTAINED OF 145, 143, 142 AND 153 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 130 MG/DL. 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 277 MG/DL AND 243 MG/DL.. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/13/2020 AND TEST STRIPS WERE OPENED TWO WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): RESULT 1: 145 MG/DL, DATE: (B)(6) 2019, TIME: 11:23PM, FASTING ( TEST WAS TAKEN ON (B)(6) 2020). RESULT 2: 102 MG/DL, DATE: (B)(6) 2019, TIME: 10:30PM, FASTING. RESULT 3: 143 MG/DL, DATE: (B)(6) 2019, TIME: 10:33PM, FASTING. RESULT 4: 142 MG/DL, DATE: (B)(6) 2019, TIME: 7:48PM, FASTING. RESULT 5: 153 MG/DL, DATE: (B)(6) 2019, TIME: 11:02PM, FASTING. RESULT 6: 76 MG/DL, DATE: (B)(6) 2019, TIME: 8:26PM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312749 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MV2949 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1