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 Codes	Chest Pain (1776); Hyperglycemia (1905); Dizziness (2194)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results.Insurance nurse is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is unknown.The customer did report symptoms of feeling dizzy and had chest pain.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 04/23/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Called customer back after his insurance agent called in to report that he sought medical intervention while using our meter.Customer states that on (b)(6) 2018, he was feeling dizzy and had chest pain.Customer states that he checked his blood sugar with our meter and the results was 308 mg/dl non-fasting, customer called the paramedic and they arrived within 10-minutes, they checked his blood sugar with their meter and the results was 402 mg/dl non-fasting.Customer was transported to the er and was diagnosed with chest pain.Customer was also treated for high blood sugar.Customer was released on (b)(6) 2018 with no new recommendation.Customer does not know his expected range.Customer states that he always tests non-fasting.Educated customer on proper way to test.Even though the comparison between the medic's meter and the metrix meter proves that the metrix is reading lower, customer states that he is not concern with low results, he is concerned with high results.Customer states that he feels well at the time of the call.

• 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: 7625398
• Report Number: 1000113657-2018-00671
• Device Sequence Number: 1318085
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/21/2018

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: MU2655
• 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: 05/29/2018
• Initial Report FDA Received Date: 06/21/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization