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

Model Number	TRUETRACK
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Headache (1880)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-41 dead battery.Test strip udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for battery issue \ dead meter.The customer stated that the meter comes on but shuts off quickly.During the call on (b)(6) 2017 it was verified that the meter came on and shut off after inserting a test strip and by manually pressing the "s" button.The strip was inserted in the meter correctly and the right brand of strips was being used.The battery was in the meter correctly.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017 the customer stated she had a headache and that it could be from diabetes.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 07/31/2018 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 6615491
• Report Number: 1000113657-2017-00965
• Device Sequence Number: 782040
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/06/2017

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: 07/31/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4872
• 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: 05/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1