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	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (bathroom).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 322mg/dl.The customer's expected fasting blood glucose test result range is 120 to 140mg/dl.The customer feels well and did not report any symptoms.The product is not stored according to specification in the bathroom.Medical attention is not reported as a result of the actual blood glucose results.The test strip lot manufacturer's expiration date is 08/23/2017 and open vial date is approximately one week ago.The meter memory was reviewed for previous test result history: (b)(6).Follow up call made to the customer in regard to an e-0 error.After troubleshooting customer obtained a high result of 322mg/dl.Customer wasn't satisfied with errors and went to local pharmacy today and was given another true metrix meter.Customer tested with new meter and obtained 256mg/dl which is close to his fasting result of 266mg.Dl obtained fasting this morning with another device.Customer felt comfortable with results from new meter.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (bathroom).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 322mg/dl.The customer's expected fasting blood glucose test result range is 120 to 140mg/dl.The customer feels well and did not report any symptoms.The product is not stored according to specification in the bathroom.Medical attention is not reported as a result of the actual blood glucose results.The test strip lot manufacturer's expiration date is 08/23/2017 and open vial date is approximately one week ago.The meter memory was reviewed for previous test result history: 322mg/dl/dl (b)(6) 2016 01:37 pm fasting: yes, 254mg/dl/dl (b)(6) 2016 06:02 pm fasting: yes, 182mg/dl/dl (b)(6) 2016 06:34 pm fasting: yes, 226mg/dl/dl (b)(6) 2016 05:00 pm fasting: yes, 260mg/dl/dl (b)(6) 2016 02:40 pm fasting: yes.Follow up call made to the customer in regard to an e-0 error.After troubleshooting customer obtained a high result of 322mg/dl.Customer wasn't satisfied with errors and went to local pharmacy today and was given another true metrix meter.Customer tested with new meter and obtained 256mg/dl which is close to his fasting result of 266mgdl obtained fasting this morning with another device.Customer felt comfortable with results from new meter.

• 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: 6234229
• Report Number: 1000113657-2017-00036
• Device Sequence Number: 1543671
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/28/2017

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: MT1633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 02/28/2017
• 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