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	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-55-user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system test strip udi#: (b)(4).Please note: customer is using same strip lot: mv2959 with both meters mentioned in complaint.See mdr ticket #:1613087.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 blood glucose test results.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 95-120mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the bathroom.Test strip lot manufacturer's expiration date is 04/20/2020, and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Complaint customer called in stating that he has two meters, and both are reading higher than his expected range.Customer is also comparing the meters to another meter.

• 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: 8264863
• Report Number: 1000113657-2019-00051
• Device Sequence Number: 14042651
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/21/2019

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: MV2959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1