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	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained results of 200, 201, 202 and 219mg/dl.The expected fasting blood glucose test result range is 130- 170mg/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 study.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is 11/3/2017.The meter memory was reviewed for previous test result history: result 1: 200mg/dl date: (b)(6) 2017 time:10:16am fasting, result 2: 168mg/dl date: (b)(6) 2017 time:4:31pm non- fasting, result 3: 201mg/dl date: (b)(6) 2017 time:8:09am fasting, result 4: 202mg/dl date: (b)(6) 2017 time:8:54pm non- fasting, result 5: 219mg/dl date: (b)(6) 2017 time:7:46am fasting.Customer just started to use this meter 3 days ago and since he used it he was getting high blood readings.He took his meter to the dr's office since his dr.Told customer that we could run a test on her meter and the true metrix meter.The dr.'s results, the customer stated, was 130mg/dl and he stated the true metrix was 170mg/dl.Yet when we went into the memory of the meter, there was no reading of 170mg/dl.I reviewed the correct way to do a side by side finger stick and he understood.The customer is also using alcohol on his fingers prior to sticking himself.Explained to wash hands prior to sticking himself.He also stated he used 2 other meters to check the true metrix and they were 30-40 pts lower than the true metrix.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause : mlc-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained results of 200, 201, 202 and 219mg/dl.The expected fasting blood glucose test result range is 130- 170mg/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 study.The test strip lot manufacturer's expiration date is (b)(6) 2018 and open vial date is 11/3/2017.The meter memory was reviewed for previous test result history: result 1 :200mg/dl date: (b)(6) 2017 time:10:16am fasting.Result 2 :168mg/dl date: (b)(6) 2017 time:4:31pm non- fasting.Result 3 :201mg/dl date: (b)(6) 2017 time:8:09am fasting.Result 4 :202mg/dl date: (b)(6) 2017 time:8:54pm non- fasting.Result 5 :219mg/dl date: (b)(6) 2017 time: 7:46am fasting.Customer just started to use this meter 3 days ago and since he used it he was getting high blood readings.He took his meter to the dr's office since his dr.Told customer that we could run a test on her meter and the true metrix meter.The dr.'s results, the customer stated, was 130mg/dl and he stated the true metrix was 170mg/dl.Yet when we went into the memory of the meter, there was no reading of 170mg/dl.I reviewed the correct way to do a side by side finger stick and he understood.The customer is also using alcohol on his fingers prior to sticking himself.Explained to wash hands prior to sticking himself.He also stated he used 2 other meters to check the true metrix and they were 30-40 pts lower than the true metrix.

• 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: 7071171
• Report Number: 1000113657-2017-02010
• Device Sequence Number: 19195019
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/12/2017

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: MU2503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1