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	Sweating (2444)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip udi#: (b)(4).Manufacturer contacted customer on (b)(6) 2016 in a follow-up call in order to ensure the customer's condition since the initial call; the customer's condition has improved since customer ate/drank after call.The customer has no diabetic symptoms or need for medical attention at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from all of the results obtained.The customer's expected fasting blood glucose test result range is 90 to 130mg/dl.The customer reported symptom of feeling sweaty.The product is stored according to specification in the bedroom.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.During the call on (b)(6) 2016, a back to back blood test was performed by the customer fasting and produced test results of 202 and 177mg/dl using true track meter.The test strip lot manufacturer's expiration date is 12/21/2018 and open vial date is approximately one month ago.The meter memory was reviewed for previous test result history: 191mg/dl (b)(6) 2016 11:58 pm fasting: yes; 370mg/dl (b)(6) 2016 01:31 pm fasting: yes; 386mg/dl (b)(6) 2016 12:44 am fasting: yes; 271mg/dl (b)(6) 2016 11:53 am fasting: yes; 376mg/dl (b)(6) 2016 04:40 pm fasting: yes.The date for the 191 mg/dl reading in the meter's memory wasn't set properly, as she had removed the battery and reinstalled without resetting the date.She mentioned that she would contact her nurse practitioner to inquire how much insulin to take if she continued to feel symptomatic since she feels as if her sugar may be low.She hadn't made any changes to her diet or medication.

• 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: 6202260
• Report Number: 1000113657-2016-02083
• Device Sequence Number: 443797
• Product Code: NBW
• UDI-Device Identifier: 00050428318010
• UDI-Public: (01)00050428318010
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: RT4931
• 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: 12/01/2016
• Initial Report FDA Received Date: 12/23/2016
• 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