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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found; no chemistry observed on test strips.Qc investigation on 1/4/2018 resulted in defect found and the event was determined to be reportable.Final root cause investigation has been completed- no chemistry due to washed strips test strip (b)(4).
Event or Problem Description
Consumer reported complaint of e-0 error: invalid hematocrit.The error occurred with multiple strips.During the call on (b)(6) 2017 the customer felt well and did not report any symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2017 as a result of the meter's readings.Customer was unable to troubleshoot at time of initial call and stated he would call back.Customer followed up on that same day and blood test was performed and produced result of e-0.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 11/24/2018 and open vial date at time of initial call is two weeks.Adverse event not reported at time of call on (b)(6) 2017.

• 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: 7205984
• Report Number: 1000113657-2018-00079
• Device Sequence Number: 13814946
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/19/2018

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: 11/24/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1