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

Model Number	STRIP, TRUE METRIX PRO50CT MG/DL
Medical Device Problem Codes	Image Display Error/Artifact (1304); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Additional report reference number: (b)(4).B2: adverse event report is being submitted due to customer going to clinic (pharmacy) due to meter results and error messages.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Test strips were returned - mixed lot, unable to test.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 01-nov-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results and error messages (e-0, e-4 and e-6) using two different vials of test strips; internal report reference (b)(4).Customer is using true metrix pro products which are designed for professional use.Customer stated he is unable to determine which results he obtained using each vial.The customer is concerned with test results from results obtained of 202, 223, 214 and 250 mg/dl.The customer¿s expected am fasting blood glucose test result is <130 mg/dl and expected pm fasting blood glucose test result range is 140-160 mg/dl.The customer feels well and did not report any symptoms.Customer stated that due to the meter results and error messages he had gone that morning (b)(6) 2023 to the clinic (pharmacy).Customer stated the pharmacist had attempted to assist but had then advised the customer to contact the manufacturer.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 03/31/2025 and test strips were opened 1-2 weeks prior to call.The meter memory was reviewed for previous test result history (date/time not set): result 1: 202 mg/dl, date: (b)(6), time: 6:15am, fasting am on (b)(6) 2023.Result 2: 223 mg/dl, date: (b)(6), time: 6:14am, fasting am on (b)(6) 2023.Result 3: 214 mg/dl, date: (b)(6), time: 8:22pm, fasting pm on (b)(6) 2023.Result 4: 250 mg/dl, date: (b)(6), time: 8:21pm, fasting pm on (b)(6) 2023.Result 5: 145 mg/dl, date: 10/07, time: 8:35pm, fasting pm on (b)(6) 2023.

• Brand Name: TRUE METRIX PRO
• Common Device Name: 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: 18055047
• Report Number: 1000113657-2023-00537
• Device Sequence Number: 6962551
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Model Number: STRIP, TRUE METRIX PRO50CT MG/DL
• Device Lot Number: ZB5393S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Distributor Facility Aware Date: 10/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown