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

Model Number	STRIP, PUBLIX 100CT TT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation, no defect was detected.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-018, user has high glucose value.Note: manufacturer contacted customer in multiple 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 hi blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.The customer¿s expected fasting blood glucose test result is 250 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 not stored according to specification (stored in the kitchen).Customer's test strips were opened more than four months ago (expired).The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was not reviewed for previous test result history.

• 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: 11290622
• Report Number: 1000113657-2021-00085
• Device Sequence Number: 3544184
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/07/2021

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: 10/31/2021
• Device Model Number: STRIP, PUBLIX 100CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5353S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Distributor Facility Aware Date: 01/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1