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 Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause:(b)(6): using incorrect test strip.Note: manufacturer contacted customer in a follow-up call on 15-feb-2024 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 low blood glucose test results.The customer is concerned with test results from results obtained of 50 and 60 mg/dl.The customer¿s expected fasting blood glucose test result is 130 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, a back to back blood test was not performed by the customer.The product is stored according to specification in a hall closet.The test strip lot manufacturer¿s expiration date is 11/22/2024 and test strips were opened 2 weeks prior to call.The customer is using the true metrix pro meter/strips (multi-patient use); replacement true metrix system was sent to customer.The meter memory was reviewed for previous test result history (only 3 results provided): result 1: 50 mg/dl date: (b)(6) 2024 time: 9:25 am fasting.Result 2: 50 mg/dl date:(b)(6) 2024 time: 9:24 am fasting.Result 3: 60 mg/dl date: (b)(6) 2024 time: pm fasting.
Additional Manufacturer Narrative
Sections with additional information as of 12-mar-2024: meter and test strips were returned for evaluation.Product testing was performed and no defect was found on returned meter and test strips.Most likely underlying root cause updated from mlc-069: using incorrect test strip to mlc-058: 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.

• 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: 18713198
• Report Number: 1000113657-2024-00064
• Device Sequence Number: 8107359
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/22/2024
• Device Model Number: STRIP, TRUE METRIX PRO50CT MG/DL
• Device Lot Number: ZB5249S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/12/2024
• 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
• Patient Sex: Unknown