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

Model Number	METRIX AIR
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Polydipsia (2604)
Date of Event	01/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: sample issue.Test strip udi# (b)(4).Note: manufacturer contacted customer on a follow-up calls in order to ensure the customer's condition since the initial call; wife stated customer had been hospitalized (b)(6) 2017.Wife stated the customer had called the ambulance on (b)(6) 2017 at 2:30 am as he had not been feeling well.Wife stated customer's blood glucose result when he had arrived at the hospital was 425 mg/dl and he was given insulin.Wife stated the hospital diagnosis was high blood sugar and low blood pressure.Wife stated the customer had been discharged from the hospital on (b)(6) 2017 was not currently experiencing any diabetic symptoms.The customer did not want to provide any further information regarding treatment received or if there were any additional blood tests performed with the alleged defective device.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error, very high blood glucose result.The e-5 error appeared after the blood was applied to the test strip.Wife is calling on behalf of the customer.The customer's expected fasting blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer reported feeling thirsty.Customer was advised to seek medical attention; it was verified no medical attention was required at that time.During the call on (b)(6) 2017, a blood test was performed by the customer and produced result of e-5 (2x).The product is stored according to specification in the dining room.The test strip lot manufacturer's expiration date is 10/31/2017 and open vial date is (b)(6) 2016.The customer is on insulin.The meter memory was not reviewed for previous test result history.

• 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: 6331906
• Report Number: 1000113657-2017-00300
• Device Sequence Number: 1022043
• Product Code: NBW
• UDI-Device Identifier: 00050428354766
• UDI-Public: (01)00050428354766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K150052
• 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): 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1800
• 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: 01/22/2017
• Initial Report FDA Received Date: 02/15/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization