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	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet 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 (b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose results.The customer is concerned with results obtained of hi.The expected fasting blood glucose test result range is 120-140mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 166 and 166mg/dl using true track.The test strip lot manufacturer's expiration date is 06/21/2019 and open vial date is 10/31/17.The meter memory was reviewed for previous test result history: result 1: 127mg/dl date: (b)(6) 2017 time: 10:42am fasting, result 2: 125mg/dl date: (b)(6) 2017 time: 6:27am fasting, result 3: 130mg/dl date: (b)(6) 2017 time: 12:58am fasting, result 4: 142mg/dl date: (b)(6) 2017 time: 10:48am non-fasting, result 5: 140mg/dl date: (b)(6) 2017 time: 8:08am fasting.Customer called in states the meter is reading high.Customer states the meter read hi non-fasting.Customer states his normal fasting range is 120-140mg/dl fasting.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.The customer is concerned with results obtained of hi.The expected fasting blood glucose test result range is 120-140mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 166 and 166mg/dl using true track.The test strip lot manufacturer's expiration date is 06/21/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer called in states the meter is reading high.Customer states the meter read hi non-fasting.Customer states his normal fasting range is 120-140mg/dl fasting.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.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).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.

• 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: 7071765
• Report Number: 1000113657-2017-02012
• Device Sequence Number: 945103
• Product Code: NBW
• UDI-Device Identifier: 00096295111866
• UDI-Public: (01)00096295111866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/06/2018

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: RU5065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY