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

Model Number	METRIX AIR
Medical Device Problem Codes	Failure to Obtain Sample (2533); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Weakness (2145); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	05/22/2017
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 6/8/2017 returned test strips produce e-2.Most likely underlying root cause of e-2 errors is due to a scratch crossing the electrodes under the spacer material.Test strip udi# (b)(4).Note: 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.
Event or Problem Description
Consumer reported complaint for meter not going to test accompanied by symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling weak, tired, frequent urination and excessive thirst.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in her purse.During the call on (b)(6) 2017, a back to back blood test was performed by the customer and produced a message of 8888 but no result using true metrix air meter.The test strip lot manufacturer's expiration date is 05/31/2018 and open vial date is 5/21/2017.The meter memory was not reviewed for previous test result history.Customer states that after inserting the test strips in the meter, meter does not go to 8888, and it shows a picture of the test strips, and then applies the blood but it does not give me a results.Customer states she was given a benadryl shot for allergies and they informed her that her blood sugar would rise as side effect.Customer is not concerns with symptoms.States that she would rest because she has a cold.

• 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: 6649034
• Report Number: 1000113657-2017-01029
• Device Sequence Number: 16375246
• 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): 06/16/2017

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: MT2251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1