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 Codes	Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi#: (b)(4).Note: manufacturer contacted customer on 11/14/2018 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.Customer left the hospital on (b)(6) 2018.Customer satisfied with the product and declined a replacement.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.The expected fasting blood glucose test result range is 140-150mg/dl.The customer did report symptoms of vomiting.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.Verified storage of product is within instructed specification since they are retained in the bedroom.The test strip lot manufacturer's expiration date is 07/25/2019 and open vial date is unknown.The meter memory was not reviewed for previous test result history.Customer was throwing up and was not feeling good.Customer had to go to the hospital.Patient is currently in the hospital since (b)(6) 2018, with a diagnosis of dka (diabetic ketoacidosis).Results at the hospital on 11/10/2018 was over 600 mg/dl fasting.Customer was treated via insulin drip.Customer is still in the hospital.Customer is feeling fine and is no longer experiencing symptoms.Customer declined a replacement meter.

• 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: 8135733
• Report Number: 1000113657-2018-01220
• Device Sequence Number: 1721561
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• 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
• Report Date (Section B): 12/05/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2761
• 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: 11/12/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization