MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
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: (b)(4) -user's test strip had poor storage (kitchen) test strip udi# (b)(4).
Event or Problem Description
Consumer initially called to order test strips.Customer mentioned she was unsure about an error message she had been getting.As customer was unsure about the error, a back to back blood test was performed fasting prior to troubleshooting and produced test results of 90 and 196mg/dl using truemetrix meter.Customer was concerned that results were erratic.Customer did not know their expected blood glucose test result range.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 not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 04/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (time not set): result 1 :196mg/dl date: (b)(6) 2017 time:01:06pm fasting.Result 2 :90mg/dl date: (b)(6) 1207 time:01:03pm fasting.Result 3 :112mg/dl date: (b)(6) 2017 time:09:35am fasting.Result 4 :171mg/dl date: (b)(6) 2017 time:06:19pm fasting.Result 5 :108mg/dl date: (b)(6) 2017 time:10:11am fasting.Customer originally called wanting to order test strips.The customer was unsure about the error she was getting so i ran a blood test with them before going through a script.Customer got a 90mg/dl at first and then we ran another to see if an error came up.Ran another blood test and customer got a 196mg/dl.These were fasting results.Customer does not know their glucose range but was alarmed at these results.

• 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: 7072659
• Report Number: 1000113657-2017-02014
• Device Sequence Number: 799786
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/30/2017

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 Expiration Date: 04/30/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1