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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-14-insufficient blood sample applied to strip (user).Test strip udi# (b)(4).Note: manufacturer contacted customer several times on a follow-up calls in order to ensure the customer's condition since the initial call; customer states that he still having blurry vision and that he has doctors' appointments for a neurologist and ophthalmologist scheduled in several weeks.Customer states his glucose level is normal and does not know if his blurry vision is due to his glucose or due to other medical condition.Customer is comfortable with the replacement product and the results he is receiving.No medical attention reported.
Event or Problem Description
Consumer reported complaint for e-2 error: sample not detected or using wrong test strip.The e-2 error occurred once the blood sample was absorbed.At the time of the call the customer reported symptom of blurry vision; medical attention was not needed at the time of the call.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test result of e-2 using truemetrix meter.The product is stored according to specification in the living room.Customer was using the correct test strips.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.

• 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: 7514800
• Report Number: 1000113657-2018-00551
• Device Sequence Number: 1760057
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: 05/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/15/2018
• 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