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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Low Test Results (2458); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2018
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-20-user's test strip had poor storage (kitchen).Test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with tests result of 49 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 140 mg/dl.Daughter stated that when customer obtained the result of 49 mg/dl fasting she was having symptoms (exact symptoms undisclosed); customer had drank orange juice to bring her blood sugar up.Customer was also obtaining a lot of error messages prior to obtaining that result.At the time of the call the customer felt 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 not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 01/20/2019 and open vial date is one week.The meter memory was reviewed for previous test result history (customer is not concerned with the results of 65 and 69 mg/dl): result 1:69mg/dl date: (b)(6) 2018 time:840am fasting; result 2:65mg/dl date: (b)(6) 2018 time:8:39am fasting; result 3:196mg/dl date (b)(6) 2018 time:10:43pm fasting; result 4:87mg/dl date: (b)(6) 2018 time:12:32pm fasting; result 5:84mg/dl date: (b)(6) 2018 time:7:27am fasting.

• 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: 7439844
• Report Number: 1000113657-2018-00440
• Device Sequence Number: 1095294
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/18/2018

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: 01/20/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1