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	Headache (1880); Hypoglycemia (1912)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-20-user's test strip had poor storage(car).Test strip udi# (b)(4).Note: manufacturer contacted customer in a follow-up call on (b)(6) 2018, to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - 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 accompanied by symptoms.The customer is concerned with meter to meter comparison: true metrix result obtained of 127 and hospital meter result of 76mg/dl.The expected fasting blood glucose test result range is unknown.The customer did report symptoms of feeling tired, flustered and having a headache.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored according to specification in the car.Test strip lot manufacturer's expiration date is 09/13/2019, and open vial date is (b)(6) 2018.Test strips expired based on open date.The meter memory was reviewed for previous test result history: (b)(6).Customer says that after a callback from doctor's office he decided to go to the er because of results from blood test done to check blood sugar levels.Customer had a routine check-up earlier that day and says results came back at 36mg/dl fasting.Before going to the er, customer says he checked his blood sugar levels after getting the phone call from his doctor's office, which was approximately 1-2 hours later, and the result was 101mg/dl (non-fasting).Customer says at the er, later that night, blood sugar levels were checked, and result was 76mg/dl on hospitals meter and 127mg/dl on true metrix meter (back-to-back test).Customer was not admitted or given any type of treatment or medications.He was diagnosed with hypoglycemia.

• 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: 8235850
• Report Number: 1000113657-2019-00019
• Device Sequence Number: 1909798
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1