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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause mlc-134-user has low glucose value.Test strip udi# (b)(4).Note: at urgent call back on (b)(6) 2018, the customer's condition had improved and she did not currently have any diabetic symptoms.No medical intervention was needed since the last call.Customer performed blood test using the truemetrix meter and obtained result of 116 mg/dl fasting.
Event or Problem Description
Consumer reported complaint for lo blood glucose test results.The customer is concerned with tests results from results obtained of lo.Customer stated that when she obtained the lo result, she was feeling dizzy and she had drank a half of a can of soda and she had felt better.The customer's expected fasting blood glucose test result range is 80 - 120 mg/dl.At the time of the call, the customer reported feeling a little dizzy; medical attention was not needed at the time of the call.Customer attempted to perform blood test during the call on (b)(6) 2018, but was unable to obtain a result despite three attempts.Customer is storing the product in her pocketbook which she takes with her when she leaves the home.The test strip lot manufacturer's expiration date is 08/26/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 7689992
• Report Number: 1000113657-2018-00757
• Device Sequence Number: 13641127
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/16/2018

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: 08/26/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2801
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/16/2018
• 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