BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 18002576 · Received October 25, 2023

    Report

    Report Number
    1000113657-2023-00528
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 25, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-028: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE: CUSTOMER CONTACT INFORMATION WAS NOT PROVIDED, MANUFACTURER UNABLE TO PERFORM FOLLOW-UP CALL TO CUSTOMER TO ENSURE THE INITIAL CONCERN IS RESOLVED.

    Description of Event or Problem · 0

    CONSUMER COMPLAINT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM (MW5145827). THE CUSTOMER ALLEGED DEFECTS WITH THE TRUE METRIX BLOOD GLUCOSE SYSTEM POTENTIALLY DUE TO TEMPERATURE AND HUMIDITY CONDITIONS, CAUSING VARIATIONS IN GLUCOSE RESULTS, AND THEREFORE, IMPACTING TREATMENT PLANS. PRODUCT INFORMATION, INCLUDING METER SERIAL NUMBER AND TEST STRIP LOT NUMBER, WAS NOT PROVIDED. EVENT DESCRIPTION - MEDWATCH: 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 BEPOSSIBLY ATTRIBUTED TO A NUMBER OF VARIABLES KNOWN TO AFFECT BLOOD GLUCOSE LEVELS. THE REPORTERPERFORMED A RETROSPECTIVE COMPARISON OF BLOOD GLUCOSE READINGS TO INDOOR AND OUTDOORATMOSPHERIC 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 POSITIVECORRELATION WAS FOUND BETWEEN FASTING BLOOD GLUCOSE AND INDOOR DEW POINT. NO CORRELATION WASFOUND BETWEEN FASTING BLOOD GLUCOSE AND OUTDOOR DEW POINT. THESE DATA CANNOT BE REPEATED ORVERIFIED 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 LEVELREADINGS 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 LABORATORYSTUDIES 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
    1733435 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, TRUE METRIX BLANKMG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown