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	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip (b)(4).Note: manufacturer contacted customer on 5/23/2018 in a follow-up call 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 or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 120 to 160 mg/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 not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 04/24/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test (b)(6).
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01566325 returned strips evaluated with no defect found.Meter not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call 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 or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 120 to 160mg/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 not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is (b)(6) 2019 and open vial date is may 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:271mg/dl date:(b)(6) 2018 time:6:45pm fasting, result 2:277mg/dl date:(b)(6) 2018 time:5:48pm fasting, result 3:249mg/dl date:(b)(6) 2018 time:3:33pm fasting, result 4:373mg/dl date:(b)(6) 2018 time:2:00pm fasting, result 5:469mg/dl date:(b)(6) 2018 time:1:30am 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: 7584472
• Report Number: 1000113657-2018-00633
• Device Sequence Number: 19213475
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/27/2018

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: MU2657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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