MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for reading of hi.The expected fasting blood glucose test result range is 200 to 300mg/d.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017 a back to back blood test was performed non-fasting by the customer and produced test results of 550 and 546 mg/dl using true track meter.The test strip lot manufacturer's expiration date is 07/13/2019 and open vial date is 08/15/2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) (b)(6).Customer refused to go the hospital; she stated that she felt fine and that she would call md.She wanted to exercise and bring down her blood sugar.She continued to state that she had taken humalog and that it had not taken effect.Customer stated that she would call her md.She stated, this is normal for her to run very high.Customer stated that she had called because she thought that the meter was broken because it was giving different back to back numbers.Customer did two back to back tests with new strips that were kept appropriately; 550mg/dl and 546mg/dl.Customer stated, she always runs high and that she did not need medical attention.Customer did not experience symptoms.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6842178
• Report Number: 1000113657-2017-01657
• Device Sequence Number: 819747
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: K032657
• 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
• Report Date (Section B): 09/05/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1