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

Model Number	STRIP, WALGREENS 100CTTT #673261
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 22-feb-2022 to ensure the initial concern is resolved - able to establish contact with customer who stated is comfortable with the glucose readings from the product.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with test results from results obtained of 69, 76, 71 and 78mg/dl.The customer¿s expected am fasting blood glucose test result is 120mg/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.The customer was not using the proper testing technique.During the call, a blood test was performed by the customer non-fasting and produced test result of 363mg/dl using true track meter; customer was satisfied with the result obtained.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 07/31/2023 and open vial date is one month ago.The meter memory was reviewed for previous test result history: result 1: 69mg/dl, date: (b)(6) 2022 ,time: 7:30 am, fasting; result 2: 76mg/dl ,date: (b)(6) 2022, time: 7:45 am ,fasting ; result 3: 71mg/dl ,date: (b)(6) 2022 ,time: 7:30 am ,fasting ; result 4: 78mg/dl ,date: (b)(6) 2022 ,time: 7:45 am ,fasting; result 5: 76mg/dl ,date: (b)(6) 2022 ,time: 7:30 am ,fasting.
Additional Manufacturer Narrative
Sections with additional information as of 26-april-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: added most likely underlying root cause onto case as the complaint product was not returned for investigation.Retention strip lot tested within specifications.Most likely underlying root cause mlc-062: user had poor technique.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13659681
• Report Number: 1000113657-2022-00115
• Device Sequence Number: 6229060
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 07/31/2023
• Device Model Number: STRIP, WALGREENS 100CTTT #673261
• Device Catalogue Number: A4H01-81
• Device Lot Number: RY5465S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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