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

Model Number	STRIP, GOOD NGHBR 50CTTT # 866576
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting ambulance due to meter result.Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-056: user had an inaccurate reference: lab results: the end user is comparing results obtained from trividia's bgm system to the results from the laboratory.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Wife is calling on behalf of the customer.Wife stated the true track is her meter but that her husband was using it and had obtained the high blood glucose test results.The customer is concerned with test results from results obtained of 529, 429 and 585 mg/dl.Wife did not know customer's expected blood glucose test result range.The customer feels well and did not report any symptoms.Wife stated that at 5:30 am on (b)(6) 2021, customer had performed a blood test and obtained a result of 429 mg/dl fasting and had administered humalog.At 8:39 am, customer had tested again and obtained a result of 529 mg/dl non-fasting and had called the ambulance.He was not experiencing any symptoms at the time, but had been concerned with the result.The ambulance had arrived 20 minutes later and performed a blood test, and customer's blood glucose test result was 270 mg/dl non-fasting.They informed customer that the humalog he had administered was working and his blood glucose was fine.No medical treatment was provided and customer was not taken to the hospital.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturers expiration date is 03/28/2023 and open vial date is (b)(6) 2021.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: 12068376
• Report Number: 1000113657-2021-00404
• Device Sequence Number: 19880504
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/25/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: STRIP, GOOD NGHBR 50CTTT # 866576
• Device Catalogue Number: A4H01-81
• Device Lot Number: RX5428S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Distributor Facility Aware Date: 06/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other