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	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet 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).Manufacturer contacted customer on (b)(4) 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 high blood glucose test results.The customer is concerned with tests results from results obtained of 160, 226 and 156 mg/dl.The customer's expected fasting blood glucose test result range is 98 - 140 mg/dl.Customer also stated that he had been comparing results to two other meters and the truemetrix meter read about 40 points higher.Actual meter to meter comparison results were not provided.Customer was using correct testing technique.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 not performed by the customer; customer was not fasting at time of call.The product is stored according to specification in the bedroom.The test strip 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).
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.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).Note: manufacturer contacted customer on 3/29/2018 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 high blood glucose test results.The customer is concerned with tests results from results obtained of 160, 226 and 156 mg/dl.The customer's expected fasting blood glucose test result range is 98 - 140 mg/dl.Customer also stated that he had been comparing results to two other meters and the truemetrix meter read about 40 points higher.Actual meter to meter comparison results were not provided.Customer was using correct testing technique.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 not performed by the customer; customer was not fasting at time of call.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is february 2018.The meter memory was reviewed for previous test result history: result 1:160mg/dl date:(b)(6) 2018 time:1:40pm fasting, result 2:226mg/dl date:(b)(6) 2018 time:1:51pm fasting, result 3:114mg/dl date:(b)(6) 2018 time:11:04am fasting, result 4:226mg/dl date:(b)(6) 2018 time:2:40pm fasting and result 5:156mg/dl date:(b)(6) 2018 time:10:00am 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: 7386000
• Report Number: 1000113657-2018-00383
• Device Sequence Number: 19105653
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 05/04/2018

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: MU2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY