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	Headache (1880)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Most likely underlying root cause of malfunction: mlc-118 user applied blood to strip before inserting strip into meter.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 e-3 accompanied by symptoms.The customer is concerned with tests results from results obtained of e-3 and symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer did report symptom of a headache.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is storage location is undisclosed.During the call on (b)(6) 2017, a blood test was performed by the customer non-fasting and produced test results of 186mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 06/22/2018.The open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer have a headache.Customer thinks it's possible because of her diabetes.Customer is getting the error as soon as the strips are inserted into the meter.Customer was putting the blood on the strips first.Customer just purchase the meter and strips and is trying to use them.After troubleshooting, customer was able to get a blood results 186mg/dl non- fasting.No replacement needed.

• 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: 6610569
• Report Number: 1000113657-2017-00954
• Device Sequence Number: 602231
• Product Code: NBW
• UDI-Device Identifier: 00050428354766
• UDI-Public: (01)00050428354766
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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: MU2297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1