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	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order 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 hi blood glucose result.Diane, wife, is calling on behalf of the customer.The customer is concerned with results obtained of hi.The expected fasting blood glucose test result range is 100-150mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The is stored by customer according to specification in the office.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 587 and 539mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 : 578mg/dl date: (b)(6) 2017 time: 7:02 pm non-fasting.Result 2 : hi date: (b)(6) 2017 time: 5:52pm fasting.Result 3 : hi date: (b)(6) 2017 time: 12:50pm uncertain.Result 4 : hi date: (b)(6) 2017 time: 4:40pm fasting.Result 5 : hi date: (b)(6) 2017 time: 11:21am non-fasting.Customer called in states the meter is reading hi.At the time of the back to back readings the customer took 10 units of insulin (humalog) 1 hour prior.

• 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: 6981186
• Report Number: 1000113657-2017-01870
• Device Sequence Number: 10933874
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: WA
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: MU2501
• 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: 10/04/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1