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	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 3/28/2017 resulted in defect found and the event was determined to be reportable.Most likely underlying root cause of high control results and e-5 errors are due to improper handling and storage: missing chemistry and residual dried chemistry.(b)(4).
Event or Problem Description
Consumer reported complaint of e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred as soon as the blood sample was absorbed.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.Blood test performed during call on (b)(6) 2017 produced result of e-3.Customer stated he stored strips in a closet but that the strips fell out of the container into water.Customer stated he patted them off and placed them back into the container.Customer stated he has been getting error message ever since.The test strip lot manufacturer's expiration date is 04/13/2018 and open vial date was undisclosed.

• 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: 6472929
• Report Number: 1000113657-2017-00640
• Device Sequence Number: 606040
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/07/2017

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: 04/13/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY