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	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated.Qc investigation on 10/31/2017 resulted in another defect found; returned test strips produce low readings and the event was determined to be reportable.Reported defect not reproduced with returned meter and test strip.The most likely root cause is due to original blood pool variation.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.During the call on (b)(6) 2017 the customer felt well and did not report any symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2017 as a result of the meter's readings.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 kitchen.The test strip lot manufacturer's expiration date is 01/31/2019 and open vial date is (b)(6) 2017.Adverse event not reported at time of call on (b)(6) 2017.

• 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: 7050217
• Report Number: 1000113657-2017-01987
• Device Sequence Number: 11170152
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 11/21/2017

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: 01/31/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1