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

Model Number	TRUEMETRIX
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-14- insufficient blood sample applied to strip (user) test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for e-2 error: sample not detected or using wrong test strip.The e-2 error occurred after the blood sample was applied.At the time of the call the customer stated she had distorted vision; medical attention was not needed at the time of the call.Customer is using correct test strips and product is stored according to the specification.During the call on (b)(6) 2018 a blood test was performed by the customer and produced e-2 error using truemetrix meter.The test strip lot manufacturer's expiration date is 09/23/2019 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: 7711718
• Report Number: 1000113657-2018-00783
• Device Sequence Number: 2643454
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• 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): 07/23/2018

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: 09/23/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2831
• 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: 06/28/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1