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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Jackie/daughter is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 317mg/dl.The customer's expected fasting blood glucose test result range is 117 and 132mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the cal on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 317 and 302mg/dl using true track meter.The test strip lot manufacturer's expiration date is 02/24/2018 and open vial date is approximately two weeks ago.The meter memory was reviewed for previous test result history: (b)(6).Daughter compared results to hospital meter that read 189mg/dl fasting and true metrix meter read 268mg/dl fasting.Customer is currently in the hospital for a bleeding ulcer.Daughter (jackie) states customer's glucose was 131 when admitted to the hospital.Daughter states admission has nothing to do with customer's diabetes or use of the meter.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause mlc-55 user had an inaccurate reference- competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.(b)(6)/daughter is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 317 mg/dl.The customer's expected fasting blood glucose test result range is 117 and 132 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 317 and 302 mg/dl using true track meter.The test strip lot manufacturer's expiration date is 02/24/2018 and open vial date is approximately two weeks ago.(b)(6).Daughter compared results to hospital meter that read 189 mg/dl fasting and true metrix meter read 268 mg/dl fasting.Customer is currently in the hospital for a bleeding ulcer.Daughter ((b)(6)) states customer's glucose was 131 when admitted to the hospital.Daughter states admission has nothing to do with customer's diabetes or use of the meter.

• 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: 6590849
• Report Number: 1000113657-2017-00902
• Device Sequence Number: 18959567
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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: RS4761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1