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	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-56-user had an inaccurate reference: lab results: the end user is comparing results obtained from trividias's bgm system to the results from the laboratory (b)(4).
Event or Problem Description
Consumer reported complaint for high and low blood glucose results.The customer is concerned with results obtained of 73 and 330mg/dl.The expected fasting blood glucose test result range is 112 to 149mg/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 product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of 134 and 146mg/dl using true merix meter.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly).Result 1 :171mg/dl date: (b)(6) 2018 time:11:26am fasting, result 2 :330mg/dl date: (b)(6) 2018 time:07:58am fasting, result 3 :73mg/dl date: (b)(6) 2018 time:02:21am fasting, result 4 :205mg/dl date: (b)(6) 2018 time:08:49pm fasting, result 5 :260mg/dl date: (b)(6) 2018 time:06:34pm fasting, customer called saying her blood sugar is not being read accurately on her meter.Customer called to complain about lower/higher/erratic readings on her meter.Customer states that the meter is not reading correctly at all.Customer took a lab test with their doctor, customer took a blood test at the same time afterwards and got a 260mg/dl fasting with their meter and a 206mg/dl fasting with the lab, and that concerned the customer.Customer tests her blood sugar and gets higher and lower results all the time.Customer states she is regularly supposed to be reading from 112-149mg/dl fasting.Customer read today at 330mg/dl fasting in the morning.Customer also tested last night and got a reading of 73mg/dl fasting, lower than what she should be reading.Informed customer not to compare results with another meter, but customer is concerned that her results are anywhere from high to low and the fact that the meter did not read 15% of the lab result that was taken at the same time in her doctor's office.

• 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: 7313317
• Report Number: 1000113657-2018-00262
• Device Sequence Number: 1476132
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/05/2018

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: MU2643
• 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: 02/06/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1