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

Model Number	METRIX AIR
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer disconnected the call; unable to send replacement product and unable to make contact with her on follow-up attempts.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 initial concern was resolved - unable to establish contact with the customer at this time.Unable to send product notification letter to customer to contact customer care.No address on file for customer.
Event or Problem Description
Consumer reported complaint for e-5 error code.The e-5 error occurred as soon as the blood sample was absorbed.Son is calling on behalf of the customer.At the time of the call on (b)(6) 2018, the customer felt well and did not report any symptoms.Son stated that on (b)(6) 2018, the customer had obtained the e-5 error on three different meters; customer was fasting at time.Information was only able to be obtained for the truemetrix air meter.Son stated that he had called 911; the paramedics had arrived and customer's blood glucose test result when tested using their meter was 556mg/dl fasting.Son had taken customer to hospital where she was diagnosed with high blood sugar and a stomach infection.Customer was given insulin and antibiotics.Customer was released on (b)(6) 2018.Customer disconnected the call and no further information was unable to be obtained.
Event or Problem Description
Consumer reported complaint for e-5 error code.The e-5 error occurred as soon as the blood sample was absorbed.Son is calling on behalf of the customer.At the time of the call on (b)(6) 2018, the customer felt well and did not report any symptoms.Son stated that on (b)(6) 2018, the customer had obtained the e-5 error on three different meters; customer was fasting at time.Information was only able to be obtained for the truemetrix air meter.Son stated that he had called 911; the paramedics had arrived and customer's blood glucose test result when tested using their meter was 556mg/dl fasting.Son had taken customer to hospital where she was diagnosed with high blood sugar and a stomach infection.Customer was given insulin and antibiotics.Customer was released on (b)(6) 2018.Customer disconnected the call and no further information was unable to be obtained.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) sections with additional information as of 29-apr-2020: h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Internal report # (b)(4).Customer disconnected the call; unable to send replacement product and unable to make contact with her on follow-up attempts.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 initial concern was resolved - unable to establish contact with the customer at this time.Unable to send product notification letter to customer to contact customer care.No address on file for customer.

• 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: 8209805
• Report Number: 1000113657-2019-00005
• Device Sequence Number: 16561673
• 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,Followup
• Report Date (Section B): 04/29/2020

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 Expiration Date: 05/24/2020
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV3017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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; SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization