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	Hyperglycemia (1905); Vomiting (2144); Lethargy (2560)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: after several attempts manufacturer contacted customer on 7/9/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer's mother states that they received the replacement product and they are satisfied.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.Mother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of vomiting, drowsy and lethargic.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 07/17/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer reported e-5 when the blood sample is absorbed.Customer is using the proper testing technique.First time that this issue has occurred.On (b)(6) 2018, mother stated that daughter was vomiting, drowsy and lethargic.Mother called 911.When emt arrived, mother stated that daughters blood glucose was over 700 mg/dl (mother unable to advise as to what the actual result was).Per customers mother, the result of 700+ obtained when the emt's arrived was a fasting result.Customer is still in the hospital.

• 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: 7674609
• Report Number: 1000113657-2018-00744
• Device Sequence Number: 848340
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: MV2750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/10/2018
• 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