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	07/20/2018
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.Product is working as designed.Most likely underlying root cause: mlc-20 - user's test strip had poor storage (kitchen).Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with test results from back to back blood tests of 286, 234, 253, and 284 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 250 mg/dl.Customer had not been using the correct testing technique for back to back tests.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 06/30/2019 and open vial date is a few days.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 112 mg/dl and 121 mg/dl using truemetrix meter.Customer had opened a new vial of test strips to perform back to back blood test during call; the lot number was not provided.The meter memory was reviewed for previous test result history: (b)(6).Customer was not doing the proper back to back technique.Customer was testing same hand, same finger.Customer is also storing strips improperly in kitchen.Customer advised not to store strips in kitchen, educated customer on proper testing technique.Customer did have changes in medication; insulin was increased and also customer was placed on a new medication atorvastatin before surgery scheduled for next week.Customer was educated and no replacement is needed.Customer advised to discard strips stored in the kitchen.Back to back testing was performed with new unopened container of strips.Lot number was not provided.Customer satisfied after testing.

• 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: 7782536
• Report Number: 1000113657-2018-00862
• Device Sequence Number: 1011884
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• 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): 08/14/2018

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: 06/30/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2739
• 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: 07/20/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1