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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Polydipsia (2604)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: 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.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 38, 49, 44 and 59 mg/dl.The customer's expected fasting blood glucose test result is 227 mg/dl.At the time of the call, the customer reported symptoms of dry mouth and increased thirst.Medical attention was not needed at the time of the call.Customer stated that when his blood glucose is reading low, he eats something sweet to try and get his sugar up.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen; customer was educated regarding proper storage.The test strip lot manufacturer's expiration date is 06/14/2019 and open vial date is one month.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: 7658602
• Report Number: 1000113657-2018-00710
• Device Sequence Number: 11265761
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/03/2018

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 Expiration Date: 06/14/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2709
• 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: 06/06/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1