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

Model Number	TRUEMETRIX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); No Information (3190)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Send a multipatient meeter appropriate for a medical facility.Most likely underlying root cause: mlc-18- user has high glucose value.Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Nurse is calling on behalf of the customer.Nurse calling requesting the owner's manual for the meter.Nurse states that the patient came in to the office and the attempted to run her blood sugar and the meter gave the e-5 error.Nurse was not sure what the error message meant so they went online and look up what the error meant.The patient was not feeling well so they send he to the hospital.No symptoms and treatment detail provided by the nurse.Customer blood sugar at the hospital was 900mg/dl.Nurse states that the patient is feeling fine now, and she did not want to provide the patient information.Nurse states that obvious the meter is doing its job and is working fine.Nurse just need the owner's manual.The customer is now feeling fine (no symptoms and no further medical attention is required.The product is stored according to specification in the office.During the call on (b)(6) 2019, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is unknown and open vial date is unknown.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: 8392006
• Report Number: 1000113657-2019-00180
• Device Sequence Number: 11134485
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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: Health Professional
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: N/A
• 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: 02/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1