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 Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Ask the customer to contact their healthcare provider due to the medical condition.Send customer test strips and control solution.Most likely underlying root cause: mlc-78- user hematocrit low.Test strip (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 and to troubleshoot the product by running controls - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-0 blood glucose results.The expected fasting blood glucose test result range is undisclosed.The customer did not report any symptoms.No medical attention reported for the actual complaint.Customer mention that has anemia.During the call on (b)(6) 2018, a blood test was performed fasting by the customer and produced test results of 113 mg/dl using true metrix meter.Customer was able to obtain a blood glucose reading during the training at the time of the call.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.Customer also mention that was hospitalized on two different occasions.Customer states that on (b)(6) 2018, he was feeling sick, he checked his blood sugar and the results was 305 mg/dl fasting.Customer went to the er, at the er, his blood sugar was 205 mg/dl fasting.Customer was diagnosed with dka, he received iv fluids, monitored over night and was released on (b)(6) 2018 mg/dl there were no new recommendations or changes to treatment plan.On (b)(6) 2018 customer had an ulcer on the right big toe which he noticed to become worse.Customer went to the er.At the er, he was diagnosed with infection to the bone.Customer's right toe was amputated and later his right leg was also amputated.Customer was released from the hospital (b)(6) 2018.Customer does not believe that either hospitalizations were due to meter's malfunction.Customer decline replacement of products.Customer was only concerned with error message.Customer does not believe that the products are inaccurate.Customer is satisfied with the product.

• 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: 7355594
• Report Number: 1000113657-2018-00328
• Device Sequence Number: 18977953
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/20/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2703
• 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: 02/21/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1