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

Model Number	TMETRIX PR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 11/13/2017 returned test strips produce high readings.Most likely underlying root cause of high control results are due to improper storage: vial left open for an extended period of time.(b)(4).
Event or Problem Description
Consumer reported complaint for high control glucose test results.Healthcare provider from a healthcare facility is calling.The customer is concerned with control test results from results obtained of 65 and 60 mg/dl.Control tests not within acceptable range of 25 - 55 mg/dl.Control level one, lot# 7bc1a20, manufacturer's expiration date is 12/31/2018 and open date is (b)(6) 2017.The product is stored according to specification in the lab at the facility.The test strip lot manufacturer's expiration date is 08/23/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.(b)(6) (healthcare provider) calling in on behalf of (b)(6) called in states the meter for control solutions is reading high result read 65 mg/dl level 1 lot#7bc1a20 range 25mg/dl-55 mg/dl also control solutions is reading high result read 60 mg/dl level 1 lot#7bc1a20 range 25mg/dl-55 mg/dl.Control solutions and test strips were stored in lab and weren't compromised.It is a facility and they were advised to discontinue the use of this meter and test strips and to please return supplies to us for investigation.Will follow up with facility for customer satisfaction.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7042506
• Report Number: 1000113657-2017-01970
• Device Sequence Number: 117878
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: Health Professional
• Device Expiration Date: 08/23/2018
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MU2365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1