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 Codes	Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-116 strip contamination that shorts assay/glucose electrodes test strip (b)(4).Manufacturer contacted customer on 08/07/2017 in a follow-up call in order to ensure the customer's condition since the initial call; the customer stated that their condition has improved and they did not report any medical intervention at this time.The customer stated that the replacement product is working to their satisfaction.
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test outside of vial too long, sample on top of test strip.The e-3 error occurred after the blood sample is applied.The customer did remove the strips from the original vial and placed them in another container for the ease of carrying them around.At the time of the call, the customer reported having frequent urination and feeling dizzy for the past two-three months.Customer stated that her doctor is aware of her symptoms.Customer declined the need for medical attention at the time of the call.The customer declined to perform a blood test during the call on (b)(6) 2017.The product is stored according to specification in the closet.The test strip lot manufacturer's expiration date is 09/16/2018 and open vial date was undisclosed.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: 6797015
• Report Number: 1000113657-2017-01564
• Device Sequence Number: 13486956
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/16/2017

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: 09/16/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2391
• 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: 07/24/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1