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	Loss of consciousness (2418)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
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-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.(b)(4).Note: manufacturer contacted customer on 10/2/2017 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 high blood glucose results accompanied by symptoms.Daughter is calling on behalf of the customer.The customer is concerned with the result of 77mg/dl compared to the paramedic result of 22mg/dl.The expected fasting blood glucose test result range is 79-112mg/dl.The customer did report symptoms of being unresponsive.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification.The test strip lot manufacturer's expiration date is 06/30/2019 and open vial date approximately three weeks ago.The meter memory was reviewed for previous test result history.(date/time not stored correctly): 1:93mg/dl (b)(6) 2017 pm fasting: no.2:266mg/dl (b)(6) 2017 pm fasting: no.3:164mg/dl (b)(6) 2017 pm fasting: no.4:253mg/dl (b)(6) 2017 pm fasting: no.5:77mg/dl (b)(6) 2017 am fasting: yes.Because of the symptoms of her mother being very listless and then unresponsive the paramedics were called.The paramedics ran a blood immediately and the results were 22mg/dl then on the true track meter 77mg/dl.Paramedics gave her an iv and the dr.Was called.Mother is at home.The customer today is feeling well.She receives her insulin once at evening the same dosage every night.The time and date are not correct in this meter.No further details regarding medical attention provided by paramedics.

• 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: 6945561
• Report Number: 1000113657-2017-01797
• Device Sequence Number: 683495
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1