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	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).Test strip (b)(4).Note: manufacturer contacted customer on 2/28/2018 in a follow-up call in order 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 since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is undisclosed however the customer did provide a recent aic of 7.6% (171 mg.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 not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Right before his tests he tested 127 mg/dl fasting on his meter and then tested 187 mg/dl fasting from venous blood in the lab.Customer is concerned that his meter may be reading lower than normal.Due to his results on the meter he was expecting a much lower a1c result and he obtained an a1c of 7.6 (171 mg/dl).Customer states that he also tested 42 and 46 mg/dl fasting on two occasions.Customer states he was feeling shaky, however, expected a reading of 80 mg/dl since he would normally feel symptoms of hypoglycemia with 80 mg/dl.Customer states time and date on meter are incorrect.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-56-user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory test strip udi#; (b)(4).Note: manufacturer contacted customer on 2/28/2018 in a follow-up call in order 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 since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is undisclosed however the customer did provide a recent aic of 7.6% (171mg.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 not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is 01/13/2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:130mg/dl date: (b)(6) 2018 time:9:16pm fasting.Result 2:125mg/dl date: (b)(6) 2018 time:10:38pm fasting.Result 3:127mg/dl date: (b)(6) 2018 time:10:56pm fasting.Result 4:42mg/dl date: (b)(6) 2018 time:10:18pm fasting.Result 5:46mg/dl date: (b)(6) 2018 time:12:35pm fasting.Right before his tests he tested 127mg/dl fasting on his meter and then tested 187mg/dl fasting from venous blood in the lab.Customer is concerned that his meter may be reading lower than normal.Due to his results on the meter he was expecting a much lower a1c result and he obtained an a1c of 7.6 (171mg/dl).Customer states that he also tested 42 and 46mg/dl fasting on two occasions.Customer states he was feeling shaky, however, expected a reading of 80mg/dl since he would normally feel symptoms of hypoglycemia with 80mg/dl.Customer states time and date on meter are incorrect.

• 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: 7352918
• Report Number: 1000113657-2018-00329
• Device Sequence Number: 1393280
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/28/2018

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: RU5161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 03/28/2018
• 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