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

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(bathroom) test strip udi# (b)(4).Note: the test strips referenced in this report are part of recall #1052693-06/13/16-001-r.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with test results from results obtained of 77, 87 and 85 mg/dl.The customer's expected fasting blood glucose test result range is 99 - 150 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 on (b)(6) 2017, 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 bathroom cabinet.The test strip lot manufacturer's expiration date is 10/14/2017 and open vial date at time of call is one month; strips are part of recall.The meter memory was reviewed for previous test result history (date/time not set): a 77mg/dl, (b)(6) 2017 05:15 pm, fasting:yes.A 87mg/dl, (b)(6) 2017 06:07 pm, fasting:yes.A 85mg/dl, (b)(6) 2017 08:27 am, fasting:yes.Memory concerns: customer is concerned with the results of 77, 87, 85 mg/dl from the meters memory.

• 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: 6604718
• Report Number: 1000113657-2017-00938
• Device Sequence Number: 1169985
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/01/2017

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 Expiration Date: 10/14/2017
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4652
• 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: 05/09/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1