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	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(kitchen) test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.(b)(6) (wife) is calling on behalf of the customer.The customer is concerned with all of the result obtained.The expected fasting blood glucose test result range is 80 to 160mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/24/2018 and open vial date is undisclosed.The meter memory was reviewed for previous test result history.The 195mg/dl (b)(6) 2017 09:46 am fasting: yes, the 258mg/dl (b)(6) 2017 12:53 am fasting: yes, the 211mg/dl (b)(6) 2017 07:27 pm fasting: no, the 188mg/dl (b)(6) 2017 01:27 am fasting: yes, the 153mg/dl (b)(6) 2017 09:07 am fasting: no.Customer states that she have two true metrix meter and she ran a blood test on both meters are giving inaccurate results.Customer run two test back to back prior to the call and got 174/ 162mg/dl non fasting using the true metrix meter.Customer then using the true results meter and ran a test and customer got a lower results.I explain to customer that the true result meter has been discontinued.Customer states that she was using the true results meter and states that the results are accurate.Customer does not have the second true metrix meter with her at this time, the meter is at the beach house.Customer states that the meter will give higher results, and then he would take his insulin and his glucose would drop low.Customer is concern with the meter giving about 30-60mg/dl higher and he is wasting a lot of strips.Customer normal glucose range is 80-160mg/dl not fasting, customer states that he normal test an hour after eating.Customer is a brittle diabetic and he test 8 times a day.Customer current vial strips (mt1987) has not been open up as yet.Customer was using lot # mt2139 and does not have any more in that vail.

• 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: 6721148
• Report Number: 1000113657-2017-01432
• Device Sequence Number: 19236199
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: MT2139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1