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 Codes	Fatigue (1849); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause mlc-18 user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer on 5/11/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer stated his condition was "somewhat better" and that he felt weak and had blurry vision.Customer stated he obtained a reading of 227 mg/dl non-fasting with the truemetrix meter.After several attempts manufacturer contacted customer on 5/21/2017 in another follow-up cal; customer states that he is well now.No medical attention and symptoms reported at the time of the call.Customer is satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.The e-5 error occurred as soon as the blood sample was absorbed.Customer stated he had tested with test strip lot # mt2249.Customer stated he had another vial of test strips (mt2261), which he used during the call on (b)(6) 2017.While troubleshooting the e-5 error, a blood test was performed by the customer non-fasting and produced test result of hi using truemetrix meter (customer stated that he had two glasses of orange juice and three eggs prior to taking this reading).During the call on (b)(6) 2017, the customer reported feeling fatigue, excess urination, thirst, blurry vision, and shaky.Customer initially denied medical attention, but prior to call ending, customer requested that 9-1-1 be called for him.9-1-1 was called and representative stayed on the line, spoke to paramedic and requested they run a blood test with their meter.Paramedic stated that their meter is also reading hi.The customer's expected fasting blood glucose test result range is 180 - 200 mg/dl.During the call on (b)(6) 2017, two additional blood tests were performed by the customer non-fasting and produced test results of e-5 using truemetrix meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 05/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: the hi (b)(6) 2017 10:14:00 am fasting:no, the 250mg/dl (b)(6) 2017 12:25:00 am fasting:yes, the 109mg/dl (b)(6) 2017 05:00:00 pm fasting:yes, the 83mg/dl (b)(6) 2017 03:11:00 pm fasting:yes, the 84mg/dl (b)(6) 2017 10:17:00 pm fasting:yes.Customer is satisfied.I did not want to disconnect the call with the customer feeling this way.I advised customer that he needs to seek medical attention in order to check his sugar.Customer states it is too far from his house.Suggested that i could call 9-1-1 for him, customer requested that i call 9-1-1 for him.I called 9-1-1 and waited on the phone until emergency arrived.I spoke to paramedic and requested them run a blood test with their meter.Paramedic states that their meter is also reading hi.Paramedic states that the proper intervention would be to escort the customer to er.Customer states he is worried that he will not have a ride back home from the hospital.Advised customer that their priority concern at this time is to lower his blood sugar and to follow what the paramedics recommend him do.Informed customer that i would follow up with him to make sure he is okay.Customer is very thankful for the help.

• 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: 6613214
• Report Number: 1000113657-2017-00962
• Device Sequence Number: 18835224
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1