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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fatigue (1849); Blurred Vision (2137); Weakness (2145)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.They request control solutions only.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call; 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 high blood glucose test results.Doctor's office is calling on behalf of the customer.At the time of the call the customer reported feeling ill with symptoms of frequent urination, blurry vision, feeling weak/tired and often hungry.Customer had gone to the diabetic educators for assistance with the meter and they had received high readings.Doctor's office called in to request control solutions to test the meter.Customer did not initially go to her diabetic educator due to diabetic symptoms or because of high results.Doctor's office realized that she had symptoms and that the results were elevated when she arrived at the office.Customer could not continue with the troubleshooting and no further information was able to be obtained.

• 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: 8305687
• Report Number: 1000113657-2019-00093
• Device Sequence Number: 154693
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: VA
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 07/16/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2747
• 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: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1