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	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18 - user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer on 7/26/2018 in a follow-up call 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 or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with test results from results obtained of hi.The customer's expected fasting blood glucose test result range is 350 mg/dl.Customer is aware that this is high and stated that her blood sugar has been high lately.Customer has only been using the truemetrix meter for a month.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of hi and e-5 using truemetrix meter.During the call, customer stated that she had not yet taken her insulin.The product is stored according to specification in the office.The test strip lot manufacturer's expiration date is 08/31/2019 and open vial date is 2 - 3 weeks.The meter memory was reviewed for previous test result history: (b)(6).Customer states that she has been trying to run her blood sugar and all she is getting is hi.Customer states that she has only been using the meter for a month now.Customer states she is feeling fine, she always has high blood sugar lately.Her normal glucose range is 350mg/dl fasting.Customer is aware that her result is this high and is not concerned that it is the meter.Customer states that she realizes she has not taken her insulin yet today.

• 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: 7759104
• Report Number: 1000113657-2018-00837
• Device Sequence Number: 1084619
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/07/2018

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 Expiration Date: 08/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2807
• 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: 07/12/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1