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 Codes	Nausea (1970); Dizziness (2194)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-30: user applied blood to strip before inserting strip into meter.Test strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and stated condition has improved.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling lightheaded and nauseous.Medical attention is not reported as a result of the actual blood glucose results or reported symptoms.The product storage location is undisclosed.During the call a blood test was performed by the customer and produced test results of 321mg/dl non-fasting using.The test strip lot manufacturer's expiration date is 12/29/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling lightheaded and nauseous.Medical attention is not reported as a result of the actual blood glucose results or reported symptoms.The product storage location is undisclosed.During the call a blood test was performed by the customer and produced test results of 321mg/dl non-fasting using.The test strip lot manufacturer's expiration date is 12/29/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 15-may-2020: h6: updated fda's method, result, and conclusion codes h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-30: user applied blood to strip before inserting strip into meter.Test strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and stated condition has improved.

• 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: 8977840
• Report Number: 1000113657-2019-00894
• Device Sequence Number: 226343
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/29/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3388S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 05/15/2020
• 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; SECOND THERAPY