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	01/21/2017
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 5/25/2017 resulted in defect found; returned test strips produce high readings 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 storage: vial left open for an extended period of time.Test strip udi# (b)(4).
Event or Problem Description
Consumer complaint of e-3 error; test strip error.E-3 error occurred upon insertion of test strip into meter port.Customer feels well and observed no 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 fasting during call on (b)(6) 2017 produced result of e-3 upon insertion of test strip into meter port.Verified storage of product is not within instructed specification since they are retained in the kitchen.Test strip lot manufacturer's expiration date is 01/19/2018 and open vial date is undisclosed.The customer does not have control solution available to perform control test.Adverse event not reported.

• 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: 6619472
• Report Number: 1000113657-2017-00972
• Device Sequence Number: 10764865
• Product Code: NBW
• UDI-Device Identifier: 00050428354766
• UDI-Public: (01)00050428354766
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/07/2017

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT1882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1