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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi#(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure the customer's condition since the initial call; on (b)(6) 2018 mother took him to the hospital the meter was doing fine but his blood sugar was very high.She did not know the results, treatment or diagnosis.She was waiting for his call to come get him.She did not gave any more information.Customer is satisfied with the product.Product is working as intended.
Event or Problem Description
Consumer reported complaint for e-5 and high blood glucose results.Mother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report symptoms.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of e-5 using true metrix air meter.The test strip lot manufacturer's expiration date is 07/25/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer was told that his blood glucose was over 900mg/dl from the lab results done at the hospital (part of routine checkup).He then tried to run his blood and got an e-5 after blood is absorbed into the strips.I explained what that meant and asked if the doctor or hospital gave instructions on what to do.Customer responded- no! i advised her to call the dr or 911 for some advice and to recheck his blood sugar -if doctor is not available.

• 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: 7634092
• Report Number: 1000113657-2018-00682
• Device Sequence Number: 2435094
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2760
• 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: 05/31/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization