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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Shaking/Tremors (2515); Polydipsia (2604)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer on 7/12/2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.The customer had medical intervention since the last call; customer had gone to the hospital on (b)(6) 2018.The customer's blood glucose test result when at the hospital was 680 mg/dl fasting.The diagnosis was high blood sugar and customer was given iv and medicine (undisclosed) in order to lower his blood glucose.The customer left the hospital the same day ((b)(6) 2018).No new medications or healthcare program was suggested but customer stated they did increase his insulin.Customer had performed additional blood test with the truemetrix meter and obtained a result of 300 mg/dl fasting.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.The customer is concerned with tests results from results obtained of hi.At the time of the call the customer stated he was shaky, drinking a lot, urinating a lot and had excessive hunger.Customer stated he would have a family member take him to the hospital.Customer could not continue with the troubleshooting process 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: 7748224
• Report Number: 1000113657-2018-00827
• Device Sequence Number: 11153296
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/03/2018

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 Expiration Date: 09/23/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2831
• 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: 07/10/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1