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	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product not returned for evaluation.Customer declined replacement product.Most likely underlying root cause: mlc-20-user's test strip had poor storage test strip udi#: (b)(4).Note: manufacturer tried to make contact customer (several attempts) in a follow-up call to ensure that the meter is working as intended - unable to establish contact at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for hi display.The expected fasting blood glucose test result range is 425mg/dl.The customer did not report symptoms, except for feeling symptoms of tiredness for the last few days.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the kitchen drawer.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is january 2019.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 8546653
• Report Number: 1000113657-2019-00387
• Device Sequence Number: 2458009
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/24/2019

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: MV2769
• 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: 03/29/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1