MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperthermia (1909); No Code Available (3191)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No meter replaced at this time.Replaced test strips only.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(basement).Test strip (b)(4).Note: unable to contact the customer via telephone at call backs on 06/29/2017,06/30/2017 and 07/03/2017.Product notification letter sent to customer to contact customer care.(b)(4).
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.Son is calling on behalf of the customer.The e-3 error occurred when the blood sample was absorbed.The customer's expected fasting blood glucose test result range is 200 - 215 mg/dl.During the call on (b)(6) 2017, the customer reported feeling hungry, body feeling warm and feeling dry mouth.Customer denied the need for medical attention at the time of the call.During the call on (b)(6) 2017, a blood test was performed by the customer fasting and produced test result of 231 mg/dl using truemetrix meter.Customer was comfortable with the result.Customer stores strips in the basement.The test strip lot manufacturer's expiration date is 01/14/2018 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 6727838
• Report Number: 1000113657-2017-01448
• Device Sequence Number: 13634673
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: MO
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 01/14/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1877
• 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: 06/28/2017
• Initial Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1