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	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause : (b)(4) user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from (b)(6) system to the results from a competitor's bgm system test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 99 and 118 mg/dl.The customer's expected fasting blood glucose test result range is 130 - 200 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.During the call on (b)(6)2017, a back to back blood test was performed by the customer non-fasting and produced test results of 143 mg/dl and 156 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 02/23/2019 and open vial date is (b)(6)2017.The meter memory was reviewed for previous test result history: a 99mg/dl, (b)(6)2017 07:16 am, fasting: yes.A 137mg/dl, (b)(6)2017 02:25 pm, fasting: yes.A 140mg/dl, (b)(6)2017 07:12 pm, fasting: yes.A 118mg/dl, (b)(6)2017 07:08 am, fasting: yes.A 133mg/dl, (b)(6)2017 08:43 pm, fasting: yes.Memory concerns: customer states that all these results are too low for him customer states that the meter is giving lower results.Customer states that he is comparing the results to the meter that his other meter and he is getting lower results.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-58 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.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 99 and 118 mg/dl.The customer's expected fasting blood glucose test result range is 130 - 200 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.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 143 mg/dl and 156 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 02/23/2019 and open vial date is 05/26/2017.The meter memory was reviewed for previous test result history: 99mg/dl (b)(6) 2017 07:16 am fasting: yes; 137mg/dl (b)(6) 2017 02:25 pm fasting: yes; 140mg/dl (b)(6) 2017 07:12 pm fasting: yes; 118mg/dl (b)(6) 2017 07:08 am fasting: yes; 133mg/dl (b)(6) 2017 08:43 pm fasting: yes.Memory concerns: customer states that all these results are too low for him customer states that the meter is giving lower results.Customer states that he is comparing the results to the meter that his other meter and he is getting lower results.

• 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: 6668586
• Report Number: 1000113657-2017-01093
• Device Sequence Number: 13470739
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 08/03/2017

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 Expiration Date: 02/23/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1