BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6741768 · Received July 25, 2017

    Report

    Report Number
    1000113657-2017-01472
    Event Type
    Malfunction
    Date Received
    July 25, 2017
    Date of Event
    July 3, 2017
    Report Date
    August 8, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS 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).

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). PRODUCT NOT YET 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).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. ERRATIC BLOOD GLUCOSE TEST RESULTS UNDER CONCERN WERE NOT REPORTED AS BEING PERFORMED BACK TO BACK. CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 66 AND 215 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 170 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/22/2017 AND OPEN VIAL DATE IS 06/18/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 113MG/DL 07/02/2017 10:00 PM FASTING: YES; 170MG/DL 07/02/2017 07:32 PM FASTING: YES; 145MG/DL 07/02/2017 01:48 PM FASTING: YES; 66MG/DL 07/02/2017 07:13 AM FASTING: YES; 215MG/DL 07/02/2017 12:34 AM FASTING: YES. MEMORY CONCERNS:CUSTOMER CONCERNED WITH RESULTS 66MG/DL AND 215MG/DL ON (B)(6) 2017.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. ERRATIC BLOOD GLUCOSE TEST RESULTS UNDER CONCERN WERE NOT REPORTED AS BEING PERFORMED BACK TO BACK. CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 66 AND 215 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 170 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/22/2017 AND OPEN VIAL DATE IS 06/18/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 113MG/DL (B)(6) 2017 10:00 PM FASTING:YES, THE 170MG/DL (B)(6) 2017 07:32 PM FASTING:YES, THE 145MG/DL (B)(6) 2017 01:48 PM FASTING:YES, THE 66MG/DL (B)(6) 2017 07:13 AM FASTING:YES, THE 215MG/DL (B)(6) 2017 12:34 AM FASTING:YES. MEMORY CONCERNS:CUSTOMER CONCERNED WITH RESULTS 66MG/DL AND 215MG/DL ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523209 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1684 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR