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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Customer satisfied after the call.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(kitchen) test strip udi# (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 - unable to establish contact with the customer at this time.Number cannot be completed as dialed.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The customer is concerned with the results reported of 226mg/dl.The expected fasting blood glucose test result range is 150 to 180mg/dl.The customer did report experiencing hyperglycemic symptoms.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product not stored according to the specifications in the kitchen.The test strip lot manufacturer's expiration date is 04/28/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer refuses to run a test at the time of call since her husband pricked his finger 4 times before contacting us.Customer was able to obtain a reading prior to the call of 226mg/dl.Customer did not advise if 226mg/dl was fasting or non-fasting.

• 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: 6671960
• Report Number: 1000113657-2017-01101
• Device Sequence Number: 19225002
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• 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): 06/27/2017

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: MT2179
• 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: 06/05/2017
• Initial Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1