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	Dizziness (2194)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (removed from original container).Note: manufacturer contacted customer on 4/20/2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer states that he just got the meter today and he have not started to use it as yet.No symptoms or medical attention reported at the time of the call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 140mg/dl.The customer did report symptoms of feeling dizzy on (b)(6) 2018.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored according to specification in another container.Customer states that he remove the strips and place them in a container so that he can easily get to them.The test strip manufacturer's expiration date is undisclosed and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer did not want to go into the meters memory to provide the results because he is old and he should not have to go through all of this to get a replacement meter.Customer went to the doctor on (b)(6) 2018 because he was feeling dizzy and he thought something was wrong with him.Customer states he is (b)(6) and he does not want to fall and because of his diabetes.Customer states that they gave him a wellness evaluation but was not given his diagnosis.Customer states that he have been getting high blood sugar.Customer states that they increase his glucophage.No treatment received.

• 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: 7494144
• Report Number: 1000113657-2018-00530
• Device Sequence Number: 16472301
• 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): 05/08/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: N/A
• 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: 04/13/2018
• Initial Report FDA Received Date: 05/08/2018
• 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