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	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strip vial returned.Test strips expired - unable to test most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen, expired strip).Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 270, 408 and 321 mg/dl.The customer's expected fasting blood glucose test result range is 160 - 180 mg/dl.At the time of the call on (b)(6) 2016, the customer felt well and did not report any symptoms.Wife stated that the customer went to emergency department on (b)(6) 2016 after getting a 518 mg/dl reading (fasting) on his meter.Customer didn't have any symptoms at that time.Wife stated at the hospital they checked his blood glucose with their meter and it was 200 points lower and that he was released that same day.During the call on (b)(6) 2016, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen cupboard.The test strip lot manufacturer's expiration date is 12/25/2016 and open vial date is (b)(6) 2016.Wife stated she had purchased the strips from a pharmacy at the beginning of december.Wife stated that she had problems with other meters and products that she had purchased from that particular pharmacy.The meter memory was reviewed for previous test result history (time not set): the 270mg/dl (b)(6) 2016 12:35 pm fasting:yes, the 408mg/dl (b)(6) 2016 08:43 pm fasting:yes, the 321mg/dl (b)(6) 2016 12:12 pm fasting:yes, the 518mg/dl (b)(6) 2016 01:53 pm fasting:yes, the 439mg/dl (b)(6) 2016 02:18 pm fasting:yes.Memory concerns: customer concerned with all results.

• 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: 6260871
• Report Number: 1000113657-2017-00085
• Device Sequence Number: 16326895
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/25/2016
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/18/2017
• 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