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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user has high glucose value test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Pharmacist is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi (non-fasting).The customer's expected blood glucose test result range was undisclosed.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 01/15/2018 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.Customer stated they would call back when they got home to troubleshoot the meter.Cvs pharmacy called for this customer which is saying that the meter is reading hi and the customer is not having any symptoms, the pharmacy wanted the customer to come in and do a blood but the customer decided to call us back when they get home and troubleshoot the meter then.

• Brand Name: METRIX AIR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6540348
• Report Number: 1000113657-2017-00780
• Device Sequence Number: 750035
• Product Code: NBW
• UDI-Device Identifier: 00050428354766
• UDI-Public: (01)00050428354766
• Combination Product (Y/N): N
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 01/15/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1878
• 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: 04/09/2017
• Initial Report FDA Received Date: 05/03/2017
• 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