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

Model Number	METRIX AIR
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vomiting (2144); Urinary Frequency / Polyuria (2275); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition has improved as they are no longer experiencing symptoms and no further medical attention is required.On (b)(6) 2018, the customer went to a diabetes center facility for assistance where she was diagnosed with diabetes ketoacidosis- 1385 mg/dl.The customer stated that she does not remember discharge dates due to going through seizures at that time.Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; spoken with the customer who stated that she has not received the replacement meter.Verified the shipping address which was not correct.We reship the product to the correct address.Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of vomiting, frequent urination, excess ketones.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of e-5 using true metrix air meter.The test strip lot manufacturer's expiration date is (b)(6) 2020 and open vial date is undisclosed.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: 8090851
• Report Number: 1000113657-2018-01192
• Device Sequence Number: 1459268
• 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): 11/20/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2936S
• 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: 10/31/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization