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	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer returned replacement meter - unable to test.Most likely underlying root cause: (b)(4)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 high blood glucose test results.The customer is concerned with tests results from results obtained of 213 and 194 mg/dl.The customer's expected fasting blood glucose test result range is 105 - 128 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 fasting and produced test results of 317 mg/dl and 350 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 12/29/2018 and open vial date at time of call is two weeks.The meter memory was reviewed for previous test result history (customer was only able to provide two results as he stated that it is too much for him to do; customer was not able to provide the date that was displayed in the meter for the results): a 213mg/dl n/a 03:08 pm fasting:yes.A 194mg/dl n/a 01:46 pm fasting:yes.Memory concerns:customer is concerned with the results of 213 mg/dl and 194 mg/dl in the meters memory.
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 high blood glucose test results.The customer is concerned with tests results from results obtained of 213 and 194 mg/dl.The customer's expected fasting blood glucose test result range is 105 - 128 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 fasting and produced test results of 317 mg/dl and 350 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 12/29/2018 and open vial date at time of call is two weeks.The meter memory was reviewed for previous test result history (customer was only able to provide two results as he stated that it is too much for him to do; customer was not able to provide the date that was displayed in the meter for the results): the 213mg/dl n/a 03:08 pm fasting:yes, the 194mg/dl n/a 01:46 pm fasting:yes.Memory concerns:customer is concerned with the results of 213 mg/dl and 194 mg/dl in the meters memory.

• 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: 6629739
• Report Number: 1000113657-2017-00987
• Device Sequence Number: 979382
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/19/2017

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: 12/29/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 06/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1