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	Dizziness (2194); No Code Available (3191)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).Note: at follow-up call on 04/15/2017 the customer stated she had vertigo but it is not related to her diabetes.The customer stated she did not currently have any diabetic symptoms and no medical intervention occured since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 240 and 202 mg/dl.The customer's expected fasting blood glucose test result range is 108 - 130 mg/dl.The customer reported feeling lightheaded, dizzy and sick; customer was unsure if it was related to her diabetes or vertigo.Customer denied need for medical attention at the time of the call.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer; customer did not have any strips that were not expired.The product is stored according to specification.The test strip lot manufacturer's expiration date is 02/28/2018 and open vial date at time of call is two weeks; customer did not have any more strips of this lot number.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns: 194mg/dl, 240mg/dl, 202mg/dl.Customer called in stating meter is reading too high.Customer states she is uncomfortable with the readings obtained.Customer no longer has any strips of the strips she was using with lot number mt1924.Customer unable to run back-to-back blood test as she does not have any strips that are unexpired.

• 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: 6552067
• Report Number: 1000113657-2017-00802
• Device Sequence Number: 10914156
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/08/2017

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: 02/28/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1924
• 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: 04/13/2017
• Initial Report FDA Received Date: 05/08/2017
• 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