MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. METRIX AIR; BLOOD GLUCOSE SYSTEM

Model Number	METRIX AIR
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 4/6/2017 resulted in defect found and the event was determined to be reportable.Most likely underlying root cause of high control results is due to improper storage: strip left outside of vial for an extended period of time.Mlurc of e-2 errors are due to ptf ink splatter and a scratch crossing the electrodes in the conductive ptf ink area test strip.Udi# (b)(4).
Event or Problem Description
Consumer reported complaint for test strip not recognizing or test strip not absorbing the blood.The customer was using proper testing technique.The meter would not read the test sample and the screen still showed it was ready to test.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.The customer was using the proper test strips.The test strip lot manufacturer's expiration date is 06/30/2017 and open vial date is 03/02/2017.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: 6508476
• Report Number: 1000113657-2017-00701
• Device Sequence Number: 13817448
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/20/2017

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: 06/30/2017
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 04/20/2017
• 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