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

Model Number	TMETRIX PR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	02/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user has high glucose value.Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer was admitted to the hospital the day of the call (b)(6) 2017.Customer was seen at the scene by paramedic (b)(6) where they then took the customer to the hospital via ambulance.Mr.(b)(6) is the paramedic that arrived to the scene of the call.Mr.(b)(6) stated that when the patient arrived at the hospital, he obtained a glucose reading of "hi" with the hospital glucose meter.Mr.(b)(6) stated that there meters can read up to 900 mg/dl then anything higher shows "hi".It was not disclosed whether it was fasting or non fasting.Mr.(b)(6) stated that he does not have an update regarding the patient and that he cannot disclose the patient's medical information due to privacy reasons.Call backs completed.
Event or Problem Description
Consumer reported complaint for e-5 error message accompanied by symptoms.(b)(6)(paramedic) is calling on behalf of the customer.The customer is concerned with tests results from results obtained of e-5 and symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of altered mental status and unresponsive on arrival.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is storage location is undisclosed.The test strip lot manufacturer's expiration date is 03/30/2018 and open vial date is about one month ago.The meter memory was reviewed for previous test result history:" (b)(6).Symptoms: paramedic is calling for his patient.Customer states that he was called to the scene for his patient displaying "altered mental status".When he arrived, the customer was unresponsive.Customer called to ask what the e-5 meant.I explained that it could be a test strip error or the blood glucose being above 600 mg/dl.Customer states that he is upset because he would have liked the meter to read hi rather than e-5 so he wouldn't have to doubt whether it's the strip or the patients glucose.Customer states that the patient was being admitted and that the blood glucose reading on the hospital hand held monitor read "hi" and that their meter goes up to 900 mg/dl.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6403683
• Report Number: 1000113657-2017-00480
• Device Sequence Number: 395339
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MT2023
• 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: 02/18/2017
• Initial Report FDA Received Date: 03/14/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization