BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8511679 · Received April 12, 2019

    Report

    Report Number
    1000113657-2019-00323
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 28, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007041
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT #(B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. 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. TEST STRIP UDI#: (B)(4). MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INDICATED THAT SYMPTOMS IMPROVED AND SHE IS FEELING WELL. AT A LATER TIME MANUFACTURER TRIED TO MAKE CONTACT CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCT IS WORKING AS INTENDED - UNABLE TO ESTABLISH CONTACT AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 69 AND 162 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 127 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING JITTERY. CUSTOMER STATED SHE WILL EAT SINCE SHE HAD NOT EATEN SINCE 3PM AND STATED THAT SHE HAD FELT JITTERY ALSO WHEN SHE HAD OBTAINED THE RESULT OF 69 MG/DL ON (B)(6) 2019; CUSTOMER HAD EATEN SOMETHING AND FELT FINE AFTER. 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 113 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND TEST STRIPS WERE OPENED ABOUT ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 113 MG/DL, DATE: (B)(6), TIME: 7:24PM FASTING; RESULT 2: 162 MG/DL, DATE: (B)(6), TIME: 5:21PM FASTING; RESULT 3: 103 MG/DL, DATE: (B)(6), TIME: 8:02AM FASTING; RESULT 4: 133 MG/DL, DATE: (B)(6), TIME: 12:14AM FASTING; RESULT 5: 69 MG/DL, DATE: (B)(6), TIME: 5:12PM FASTING.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT # (B)(4). PRODUCT 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. TEST STRIP UDI#: (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER SYMPTOMS IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO INDICATED THAT SYMPTOMS IMPROVED AND SHE IS FEELING WELL. AT A LATER TIME MANUFACTURER TRIED TO MAKE CONTACT CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCT IS WORKING AS INTENDED - UNABLE TO ESTABLISH CONTACT AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 69 AND 162 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 127 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING JITTERY. CUSTOMER STATED SHE WILL EAT SINCE SHE HAD NOT EATEN SINCE 3PM AND STATED THAT SHE HAD FELT JITTERY ALSO WHEN SHE HAD OBTAINED THE RESULT OF 69 MG/DL ON (B)(6) 2019; CUSTOMER HAD EATEN SOMETHING AND FELT FINE AFTER. 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 113 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND TEST STRIPS WERE OPENED ABOUT ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301310 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2829 00021292007041

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY