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	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (bathroom).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 167mg/dl.The customer's expected fasting blood glucose test result range is 61 and 130mg/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 product is not stored according to specification in the bathroom.The test strip lot manufacturer's expiration date is 01/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: 167mg/dl (b)(6) 2017 06:38:00 am fasting: yes; 143mg/dl (b)(6) 2017 12:30:00 pm fasting: yes; 141mg/dl (b)(6) 2017 02:28:00 am fasting: yes; 154mg/dl (b)(6) 2017 03:08:00 am fasting: yes; 134mg/dl (b)(6) 2017 01:33:00 pm fasting: yes.Customer called because endocrinologist asked patient to have meter changed out immediately because hga!c - 9.5 and that he could not trust the meter.Customer denies having sign or symptoms of hyperglycemia.Customer stored strip inappropriately and refuses any medical care.Customer went to doctor's office as a routine visit.

• 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: 6325578
• Report Number: 1000113657-2017-00266
• Device Sequence Number: 11189954
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/13/2017

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: RS4742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY