BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX GLUCOSE MONITOR

    MDR report key: 17773369 · Received September 18, 2023

    Report

    Report Number
    MW5145827
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    September 14, 2023
    Report Date
    September 14, 2023
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CONSUMER HAS BEEN SELF-MONITORING BLOOD GLUCOSE ON REGULAR BASIS FOR SEVERAL YEARS. THE CONSUMER CONSULTS WITH DIETITIAN/MEDICAL DOCTOR/PHYSICIAN ASSISTANTS TO OPTIMIZE CONTROL OF BLOOD GLUCOSE. IN 2023 THE FASTING BLOOD GLUCOSE LEVELS APPEARED TO CHANGE INCONSISTENTLY AND COULD BE POSSIBLY ATTRIBUTED TO A NUMBER OF VARIABLES KNOWN TO AFFECT BLOOD GLUCOSE LEVELS. THE REPORTER PERFORMED A RETROSPECTIVE COMPARISON OF BLOOD GLUCOSE READINGS TO INDOOR AND OUTDOOR ATMOSPHERIC CONDITIONS FOR SEVERAL MONTHS. SUBJECTIVE COMFORT LEVEL AND SUBJECTIVE SLEEP QUALITY AND HIGHER BLOOD SUGAR APPEARED TO BE RELATED TO HUMID WEATHER AND ESPECIALLY FOG. A POSITIVE CORRELATION WAS FOUND BETWEEN FASTING BLOOD GLUCOSE AND INDOOR DEW POINT. NO CORRELATION WAS FOUND BETWEEN FASTING BLOOD GLUCOSE AND OUTDOOR DEW POINT. THESE DATA CANNOT BE REPEATED OR VERIFIED BY OTHERS AND THEREFORE NOT INCLUDED IN THIS REPORT. REPORTER CONDUCTED 3-POINT CONTROL MEASUREMENTS WITH CONTROL SOLUTION OBTAINED FROM THE MANUFACTURER TO ASCERTAIN IF EQUIPMENT ERROR CONTRIBUTED TO THE ABNORMAL FASTING GLUCOSE READINGS FOR THE LAST WEEK. CONTROL LEVEL READINGS WERE WITHIN NORMAL LIMITS BUT POSITIVELY CORRELATED WITH INDOOR DEW POINT. CORRELATION COEFFICIENT WAS + 0.6. THE CONSUMER CHANGED THE MEDICATION ROUTINE UNDER MEDICAL SUPERVISION AND DOCTOR ORDER. THE RANGE OF LEVEL II CONTROL SOLUTION READINGS WAS 16 MG/DL AND THE RANGE OF INDOOR DEW POINT WAS 4 DEGREES CENTIGRADE. THE CONSUMER SUBSEQUENTLY PURCHASED ANOTHER TYPE OF BLOOD GLUCOSE METER. THE REPORTER CONDUCTED A LITERATURE SEARCH TODAY AND FOUND SEVERAL LABORATORY STUDIES THAT CONFIRM HUMIDITY AND TEMPERATURE HAVE BEEN SHOWN TO AFFECT GLUCOSE METERS. THE CONSUMER HAS ENDURED MULTIPLE PROBLEMS THAT COULD BE ATTRIBUTED TO SUB OPTIMAL GLUCOSE CONTROL. IT IS UNCLEAR IF THE MONITOR CORRELATION WITH INDOOR HUMIDITY CONTRIBUTED TO OR CAUSED THE COMPLICATIONS, SO SPECULATION IS NOT INCLUDED IN THIS REPORT. THE CORRELATION OF BLOOD GLUCOSE READINGS WITH INDOOR ATMOSPHERIC CONDITIONS CAN BE READILY REPEATED AND VERIFIED IN OTHER SETTING SO THAT IS THE ISSUE REPORTED TO THE FDA. DURING MANY YEARS OF MEDICAL MANAGEMENT OF THIS MEDICAL PROBLEM, THE CONCEPT OF HEAT AND HUMIDITY HAS NOT BEEN MENTIONED OR CONSIDERED WHEN PRESCRIBING DRUGS AND MODIFYING DIET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062333 TRUE METRIX GLUCOSE MONITOR SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown