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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-78- user hematocrit low.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - 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 e-0 result the expected fasting blood glucose test result range is undisclosed.Customer didn't have symptoms at the time of the call.The customer did report being found unconscious on a previous occasion.Medical attention is reported as a result of the reported event.The product storage location is undisclosed.During the call back to back blood test was not performed.The test strip lot manufacturer's expiration date is 06/18/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.On the previous event, customer was found unconscious by a family member and was transported to the hospital via 911.Customer woke up a few days later.Customer states he had several broken ribs because of cpr conducted.Apparently, the customer had a heart attack as well.Medical intervention was required but customer is not sure if it was because he was hospitalized because of hyperglycemia or his heart attack.He does not remember much about the dates and time.Customer did not disclose when admitted to hospital but stated they had high blood glucose levels at hospital of 1000mg/dl (unknown if fasting or non-fasting) did not want to disclose any further information about treatment or diagnosis.He did however state he was later prescribed blood thinner medication and blood pressure medication.Customer became vulgar during the phone call.Customer denied symptoms or medical attention at time of call.

• 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: 7455831
• Report Number: 1000113657-2018-00473
• Device Sequence Number: 19072417
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/24/2018

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2716
• 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: 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization