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

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-62-user had poor technique 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.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Wife is calling on behalf of the customer.The customer is concerned with tests results from back to back blood tests of 555 and 174 mg/dl and 152 and 448 mg/dl.Customer is not concerned that the results were high.The customer's expected fasting blood glucose test result range is 120 - 140 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 171 mg/dl and 167 mg/dl using truemetrix meter.The product is stored according to specification in the bedroom.The test trip lot manufacturer's expiration date is 05/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).Customer called stating his blood sugar is reading erratically.Customers regular fasting range is 120-140mg/dl.Customer got a reading of 448mg/dl fasting and then 152mg/dl fasting within a minute from each other.Customer also got a reading of 555mg/dl fasting and then a reading of 174mg/dl fasting just 2 minutes afterwards.Cusotmer is primarily concerned with erratic results and he is not concerned with the higher results.

• 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: 7477637
• Report Number: 1000113657-2018-00504
• Device Sequence Number: 13734118
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/01/2018

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: 05/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2701
• 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: 04/05/2018
• Initial Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1