MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Sweating (2444)
Date of Event	10/17/2018
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 udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure the customer's condition since the initial call and 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.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all the results obtained.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling sweaty, 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 in the dining room.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 03/19/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): result 1:197mg/dl date: (b)(6) 2018 time:2:50pm fasting; result 2:230mg/dl date: (b)(6) 2018 time:2:48pm fasting; result 3:223mg/dl date: (b)(6) 2018 time:2:45pm fasting; result 4:164mg/dl date: (b)(6) 2018 time:12:19pm fasting; result 5:266mg/dl date: (b)(6) 2018 time:9:16am fasting; customer is not sure what her normal glucose range should be, customer have not testing in years customer and just started testing again today.Customer just got the meter because she will be having surgery soon and she needs to monitor her diabetes.Customer is concern because she is not eating hardly any carbs or sugar.Customer states that she is in a lot of pain (not related to diabetes), customer is only taking extra strength tylenol for her pain.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8057074
• Report Number: 1000113657-2018-01156
• Device Sequence Number: 11288998
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K140100
• 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): 11/09/2018

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1