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 Codes	Hyperglycemia (1905); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Customer satisfied with the product.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4).Manufacturer contacted customer on (date) in a follow-up call in order to ensure the customer's condition since the initial call; unable to contact the customer via telephone at call backs on 12/26/2017 and 12/28/2017.At call back on (b)(6) 2017 the customer's condition had improved and they did not currently have any diabetic symptoms.The customer stated that the paramedics had taken her to the hospital on (b)(6) 2017.The customer's blood glucose test result when at the hospital was 900 mg/dl fasting.The hospital diagnosis was high blood sugar and the customer was given iv and insulin.The customer left the hospital (b)(6) 2017.There were no new medications/healthcare program suggested.An additional blood test performed with the truemetrix air meter produced result of 465 mg/dl fasting.Customer declined replacement of product as she believes meter is working as designed.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.Husband is calling on behalf of the customer.The e-5 error occurred as soon as the blood sample was absorbed.The customer's expected blood glucose test result range was undisclosed.At the time of the call the customer reported symptoms of dry mouth and increased urination.Customer was going to go to the hospital.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 09/22/2018 and open vial date was 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: 7195982
• Report Number: 1000113657-2018-00069
• Device Sequence Number: 854196
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2018

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 Expiration Date: 09/22/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2401
• 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: 12/22/2017
• Initial Report FDA Received Date: 01/16/2018
• 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