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	Urinary Frequency / Polyuria (2275); Polydipsia (2604); No Code Available (3191)
Date of Event	10/20/2017
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 had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Note: manufacturer contacted customer on (b)(4) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; the customer's condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.No additional blood tests were performed with the truemetrix meter.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Granddaughter is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 516, 431, 338, 355 and 477 mg/dl.The customer's expected fasting blood glucose test result range is 100 - 200 mg/dl.At the time of the call, the customer reported symptoms of dry mouth, increased thirst and frequent urination.Customer declined the need for medical attention at the time of the call.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 533 mg/dl and 523 mg/dl using truemetrix meter.The product is stored according to specification in the dining room.The test strip lot manufacturer's expiration date is 12/26/2018 and open vial date at time of call is one week.The meter memory was reviewed for previous test result history: result 1 : 516 mg/dl date: (b)(6) 2017 time: 3:44pm fasting; result 2 : 431mg/dl date: (b)(6) 2017time: 12:14pm fasting; result 3 : 338mg/dl date: (b)(6) 2017time: 12:26pm fasting ; result 4 : 355mg/dl date: (b)(6) 2017time: 3:34pm fasting; result 5 : 477mg/dl date: (b)(6) 2017 time: 2:18pm fasting.Concerned with all results being high.

• 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: 7010197
• Report Number: 1000113657-2017-01919
• Device Sequence Number: 1184757
• Product Code: NBW
• UDI-Device Identifier: 00021292007065
• UDI-Public: (01)00021292007065
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/08/2017

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: 12/26/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1