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	Fatigue (1849); Weakness (2145)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc- 118 -user applied blood to strip before inserting strip into meter.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Unable to send product notification letter as no address on file for customer.
Event or Problem Description
Consumer reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred when the blood sample was absorbed.Customer stated she had not taken her medication because she had not been able to test.During the call on (b)(6) 2017, a blood test was performed by the customer fasting and produced test result of 57mg/dl using truemetrix air meter.The customer's expected fasting blood glucose test result range was undisclosed.At the time of the call the customer reported feeling weak and tired; medical attention was not needed at the time of the call.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 02/22/2019 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: 7186100
• Report Number: 1000113657-2018-00048
• Device Sequence Number: 13827132
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• 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): 01/12/2018

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 Expiration Date: 02/22/2019
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2595
• 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: 12/19/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1