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

Model Number	TMETRIX PR
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.(empty strip vial returned).Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results, multiple error codes and medical attention.(b)(6)-support manager, is emailing on behalf of the customer.The customer is concerned with tests results from results obtained of 126 and 142mg/dl.The product is storage location is undisclosed.The test strip lot manufacturer's expiration date is 04/30/2018 and open vial date is undisclosed.The meter memory was reviewed for previous test result history (date / time not set): (b)(6).Concerns are the 126 and the 142mg/dl from the meter's memory.This was an email.The report having a patient who was presenting with signs of stroke.Testing the patient's blood glucose in the ambulance with this meter and getting a result of 126mg/dl.When they got to the emergency room, the blood glucose was re-checked with the hospital system (unknown as to what system is) and the blood glucose result was 26mg/dl for which the patient required immediate treatment for sever hypoglycemia.The date was possibly (b)(6) 2017, and there is such a result in this meter for that date.They also reported another incident with this meter where the blood glucose of the patient testes in the ambulance at 142mg/dl and then it was 32mg/dl when tested in the emergency room with the er's blood glucose system (unknown as to which system).The date was possibly (b)(6) 2017 and there is such result in this meter for that date.This meter also has a control solution result stored , but there is no date/time and no result, only a dash line across the meter face.They complain of receiving multiple error code e0, e2,e-3, e4 and e-5 but i cannot tell if that complaint is specific to this meter.No information regarding whether the results were taken fasting on the expected blood results.

• 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: 6463892
• Report Number: 1000113657-2017-00629
• Device Sequence Number: 476141
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MT2216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/06/2017
• 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