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	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is undergoing an evaluation but has not yet been completed.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of 228, 353 and 279 mg/dl.The customer's expected fasting blood glucose test result range is 160 - 200 mg/dl.Customer was not using correct testing technique for the back to back tests.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) 2018, a back to back blood test was not performed by customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is two weeks.The meter memory was reviewed for previous test result history (date/time not set; results of 388 and 298 mg/dl are not customer's results, they are her husband's results): result 1:228mg/dl (b)(6) 8:09am fasting; result 2:353mg.Dl (b)(6) 8:05am fasting; result 3:279mg/dl (b)(6) 8:04am fasting; result 4:388mg/dl not customer's result, this is her husband's result; result 5:298mg/dl not customer's result, this is her husband's result; result 6:182mg/dl (b)(6) 6:52am fasting; result 7:134mg/dl (b)(6) 2:25pm fasting.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of 228, 353 and 279 mg/dl.The customer's expected fasting blood glucose test result range is 160 - 200 mg/dl.Customer was not using correct testing technique for the back to back tests.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) 2018, a back to back blood test was not performed by customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is two weeks.The meter memory was reviewed for previous test result history (date/time not set; results of 388 and 298 mg/dl are not customer's results, they are her husband's results): (b)(6).
Additional Manufacturer Narrative
(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.(b)(4).Note: manufacturer contacted customer on 10/16/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of 228, 353 and 279 mg/dl.The customer's expected fasting blood glucose test result range is 160 - 200 mg/dl.Customer was not using correct testing technique for the back to back tests.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 10/01/2018, a back to back blood test was not performed by customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is two weeks.The meter memory was reviewed for previous test result history (date/time not set; results of 388 and 298 mg/dl are not customer's results, they are her husband's results): result 1:228mg/dl, 3/22 8:09am, fasting; result 2:353mg.Dl, 3/22 8:05am, fasting; result 3:279mg/dl, 3/22 8:04am, fasting; result 4:388mg/dl, not customer's result, this is her husband's result; result 5:298mg/dl, not customer's result, this is her husband's result; result 6:182mg/dl, 3/18 6:52am, fasting; result 7:134mg/dl, 3/17 2:25pm, fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = t) 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).Note: manufacturer contacted customer on 10/16/2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.Correction: correct the evaluation codes on section h reflecting the device evaluation.

• 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: 8009299
• Report Number: 1000113657-2018-01105
• Device Sequence Number: 16442873
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/02/2018

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 Expiration Date: 05/31/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/01/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/02/2018
• 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; SECOND THERAPY; SECOND THERAPY