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	07/06/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage.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
Customer calling concerned her meter is displaying results that she considers are low for her.Customer meter reading results of 87 mg/dl this morning fasting.Customer expected blood glucose ranges of 96 mg/dl-140 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported because of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification.The test strip lot manufacturer's expiration date is 9/30/2017 and open vial date is (b)(6) 2015.The meter memory was reviewed for previous test result history: 104mg/dl (b)(6) 2015 09:00:00 am fasting:yes; 90mg/dl (b)(6) 2015 03:00:00 pm fasting:no; 165mg/dl (b)(6) 2015 04:15:00 pm fasting:no; 111mg/dl (b)(6) 2015 05:30:00 pm fasting:no; 94mg/dl (b)(6) 2015 06:15:00 pm fasting:no.

• 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: 6706707
• Report Number: 1000113657-2017-01371
• Device Sequence Number: 19111335
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: YES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• 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