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	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (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 7/17/2018 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 test results.The customer is concerned with test results from results obtained of 294, 252 and 274 mg/dl.Customer was also concerned with back to back fasting blood test results performed during the call using truemetrix meter of 316 and 309 mg/dl.The customer's expected fasting blood glucose test result range is 110 - 120 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.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is 05/10/2018.The meter memory was reviewed for previous test result history: (b)(6).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 294, 252 and 274 mg/dl.Customer was also concerned with back to back fasting blood test results performed during the call using truemetrix meter of 316 and 309 mg/dl.The customer's expected fasting blood glucose test result range is 110 - 120 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.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is 05/10/2018.The meter memory was reviewed for previous test result history: result 1 :316mg/dl, date: (b)(6) 2018, time:12:33pm, fasting; result 2 :309mg/dl, date: (b)(6) 2018, time:12:33pm, fasting; result 3 :294mg/dl, date: (b)(6) 2018, time:11:35pm, fasting; result 4 :252mg/dl, date: (b)(6) 2018, time:02:15pm, fasting; result 5 :274mg/dl, date: (b)(6) 2018, time:11:18pm, fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report #: (b)(4) returned meter evaluated with no defect found.Test strips not returned for evaluation.Test strip vial with different lot# returned.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 udi#: (b)(4).Note: manufacturer contacted customer on 7/17/2018 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.

• 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: 7747964
• Report Number: 1000113657-2018-00825
• Device Sequence Number: 1258320
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/14/2018

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: 10/31/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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