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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275)
Date of Event	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer on 8/17/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer stated her condition had improved and she did not currently have any diabetic symptoms.Customer stated she had gone to the er on (b)(6) 2017.Customer stated her blood glucose lab result when at the hospital was 640 mg/dl (not stated if fasting or non-fasting).Customer stated the diagnosis was ketoacidosis.Customer stated she was given two doses of ten units of insulin.Customer left the er the same day.Customer has an additional meter and declined to have a replacement sent.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.The e-5 error occurred as soon as the blood sample was absorbed.The customer had not been able to test since (b)(6) 2017.The customer has two truemetrix meters and both displayed the e-5 error message.The customer was using the proper testing technique.The customer's expected blood glucose test result range was undisclosed.At the time of the call, the customer reported symptoms of blurry vision and frequent urination.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 08/17/2018 and open vial date at the time of the call was a few days.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: 6843407
• Report Number: 1000113657-2017-01662
• Device Sequence Number: 819790
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• 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): 09/05/2017

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: 08/17/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2356
• 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: 08/16/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1