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	08/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: user's test strip had poor fill.Based on review with fda on 06/21/2017, we verified the agency's interpretation of the act and submit this medwatch report based on the nature of the complaint for this recalled lot.Fda-assigned recall event id 74805.
Event or Problem Description
Consumer reported complaint for low results.Customer's expected results are 90-100mg/dl - fasting.Strip expiration date is 07/31/2017 and strip open date is (b)(6) 2015.Strip storage is correct.Back to back blood test performed adn results are 60mg/dl and 68mg/dl - fasting.Reviewed meter memory (time not set): 64mg/dl (b)(6) 2015 01:10:00 pm fasting:yes; 67mg/dl (b)(6) 2015 01:08:00 pm fasting:yes; 184mg/dl (b)(6) 2015 11:33:00 am fasting:yes; 164mg/dl (b)(6) 2015 10:13:00 am fasting:yes; 133mg/dl (b)(6) 2015 08:32:00 pm fasting:yes.Customers concern: 64 mg/dl on (b)(6) 2015 and 67 mg/dl.The customer is testing twice a day (fasting) and is not on any medication or has made any changes in her diet.The customer is feeling fine.The customer is storing the meter in the living room.

• 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: 6705570
• Report Number: 1000113657-2017-01412
• Device Sequence Number: 13712724
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888(17)170731(10)RS4608
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/12/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1