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	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Most likely underlying root cause: (b)(4) user has high glucose value.Test strip udi# (b)(4).Note: 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 reading.Receptionist is calling on behalf of the customer who is also present.The customer is concerned with results of hi.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did/ did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results the product storage location is undisclosed.During the call on (b)(6) 2017, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 04/18/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer refused to continue trouble shooting.Called ended after the customer states that he will called his doctor.Customer sates he feels well but his blood sugar runs in the 800mg/dl.Explained to customer that a hi means that his blood sugar may be over 600mg/dl.Customer is newly diagnose, customer stated that with other products his blood sugar has run over 800mg/dl, he wanted to know what does a hi means because the true metrix meter read hi.Customer refused to continue troubleshooting.

• 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: 7173226
• Report Number: 1000113657-2018-00034
• Device Sequence Number: 896339
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• 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): 01/08/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2652
• 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: 12/14/2017
• Initial Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1