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

Model Number	STRIP, CVS 50CT TT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 30-mar-2021 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 blood glucose test results.Son is calling on behalf of the customer.The customer is concerned with test results from results obtained of 452, 381, 340 and 447 mg/dl.Customer was also comparing results obtained using the truetrack meter to another device, and stated the truetrack results were higher; actual meter to meter comparison results were not provided.The customer¿s expected fasting blood glucose test result is less than 150 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 the dining room.The test strip lot manufacturer¿s expiration date is 12/22/2022 and the test strips were opened a few days prior to call.The meter memory was reviewed for previous test result history: (b)(6).

• Brand Name: TRUETRACK
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11666882
• Report Number: 1000113657-2021-00257
• Device Sequence Number: 14411350
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 12/22/2022
• Device Model Number: STRIP, CVS 50CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5414S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Distributor Facility Aware Date: 03/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1