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 Code Available (3191)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user has high glucose value.Test strip (b)(4).Note: 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's conditioned improved and they are no longer experiencing symptoms.However, he did go to the hospital on (b)(6) 2017 and was treated with insulin via iv.He was discharged on (b)(6) 2017.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 554 and 519 mg/dl.The customer's expected fasting blood glucose test result range is 130 to 140 mg/dl.The customer did report feeling droggy.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms at the time of the call.The product is stored according to specification.During the call on (b)(6) 2017 a back to back blood test was performed by the customer fasting and produced test results of 554 and 519 mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 04/28/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): 1:554 mg/dl (b)(6) 2017 09:25 am fasting: yes, 2:519 mg/dl (b)(6) 2017 09:30 am fasting: yes.Customer called because blood glucose was elevated.Customer is going to go to "doc in the box" and customer has been on prednisone.Customer does not have hga1c.Customer has new infection- yeast infection.Customer on new medication- mystatin 100,000 units/ml and he just started taking this 4 times a day.New medication- fluconazole 100 mg tablet 1 tablet for 7 days.Date/time not set correctly.

• 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: 6538306
• Report Number: 1000113657-2017-00774
• Device Sequence Number: 97512
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/02/2017

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2179
• 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: 04/07/2017
• Initial Report FDA Received Date: 05/02/2017
• 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