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

Model Number	TRUETRACK
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Test strips not returned for evaluation.Returned meter evaluated with defect found.On the investigation on 7/10/2018 resulted in defect found.Meter meter displays partial characters.The meter does not produce an e-4 or partial e-4 when running a blood glucose test.Based on the result the event was determined to be reportable.Final root cause : meter displays partial characters due to user mechanical stress.Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the initial concern was resolved.No symptoms or medical attention reported.
Event or Problem Description
Consumer reported complaint for defective lcd.Friend is calling on behalf of the customer.Customer states the characters are fading, and it is hard to see the last digit.Customer is seeing partial characters.Last medication taken was when his meter may have read 150 mg/dl fasting with no adverse effect on the patient since the only digit of the numbers affected was the last digit.The meter was not dropped or mishandled.The customer feels well and did/ did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 08/13/2019 and open vial date is 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: 7704782
• Report Number: 1000113657-2018-00773
• Device Sequence Number: 600521
• Product Code: NBW
• UDI-Device Identifier: 00021292008932
• UDI-Public: (01)00021292008932(17)190813(10)RU5088
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/19/2018

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1