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	Hyperglycemia (1905)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product letter send to customer to contact customer care.On (b)(6) 2017 customer contact us and stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained results of 575mg/dl.The expected fasting blood glucose test result range is 145 to 165mg/dl.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 306 and 374mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 07/20/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: -true metrix 331mg/dl date: (b)(6) 2017 time: 5:58pm not fasting.- true metrix 392mg/dl date: (b)(6) 2017 time: 4:00pm not fasting.- true metrix 306mg/dl date: (b)(6) 2017 time: 6:43pm not fasting.- true metrix 374 mg/dl date (b)(6) 2017 time: 6:44pm not fasting.Customer went to hospital regarding high reading of 575 mg/dl fasting.Customer at hospital had a reading of 499 mg/dl lab fasting.Customer was admitted and released on (b)(6) 2017 for hyperglycemia.Customer states they were released with a reading of 381 mg/dl fasting on (b)(6) 2017.Customer sought an endocrinologist and was put on a sliding scale of humalog.

• 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: 7048739
• Report Number: 1000113657-2017-01982
• Device Sequence Number: 1798735
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• 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): 11/21/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1