MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number METER, TRUE METRIX BLANKMG/DL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 18002576
• MDR Text Key: 326468492
• Report Number: 1000113657-2023-00528
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: METER, TRUE METRIX BLANKMG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/02/2023
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1