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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-62-user had poor technique test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.Friend is calling on behalf of the customer.The e-3 error occurred when the test strip was inserted into the meter.At the time of the call, the customer reported feeling dizzy.Customer was using proper testing technique.The test strip was not left out of the vial too long and customer stated he did not leave the vial open.During the call on (b)(6) 2018, a blood test was performed by the customer non-fasting and produced test result of 213 mg/dl using truemetrix meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 09/16/2019 and open vial date is (b)(6) 2018.

• 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: 7918568
• Report Number: 1000113657-2018-00978
• Device Sequence Number: 1594342
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: 09/16/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2822
• 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: 09/04/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1