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	11/01/2017
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-18- user has high glucose value.(b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose results.(b)(6),father, is calling on behalf of the customer.The customer is concerned with results obtained results of hi.The expected fasting blood glucose test result range is 150 to 200mg/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 dining room.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 572 and 479mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 10/21/18 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly): result 1 : hi mg/dl date: (b)(6) time: 5:58 pm fasting, result 2 : hi mg/dl date: (b)(6) time: 4:43 pm fasting, result 3 : hi mg/dl date: (b)(6) time: 3:37 pm fasting, result 4 : 527 mg/dl date: (b)(6) time: 12:36 pm fasting, result 5 : 499 mg/dl date: (b)(6) time: 10:32 pm fasting.Father stated that when son tested numerous times today, he got a blood glucose result of hi.Customer's father stated that his son's blood glucose has never ran this high before.

• 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: 7048880
• Report Number: 1000113657-2017-01983
• Device Sequence Number: 1004488
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/21/2017

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: MU2443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1