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

Model Number	TRUETRACK
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-68- user did not insert code key.Test strip udi# (b)(4).Note: 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 code eci meter.During the call on (b)(6) 2018, a check strip test was performed.Customer removed and properly reinserted the code chip and test strip and the error message still displayed.A new vial of test strips was used, same lot number, and the error message still displayed.The test strip manufacturer's expiration date is 12/21/2020.At the time of the call, the customer was feeling ill and reported symptoms of dizziness and nausea.Customer stated he would go to the hospital.No medical attention was reported at the time of the call.

• 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: 8073426
• Report Number: 1000113657-2018-01161
• Device Sequence Number: 1616332
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/15/2018

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 Expiration Date: 12/21/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5276
• 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: 10/19/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1