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

Model Number	METRIX AIR
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144)
Date of Event	04/30/2018
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 on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer was admitted to hospital on (b)(6) 2018 for hyperglycemia (blood glucose of 1080mg/dl).Customer had to have urgent dialysis treatment.Customer is blind, has difficulty testing, and lives alone.Therefore, he has not been able to monitor himself and take his insulin properly.Manufacturer contacted customer on a follow-up call to ensure the customer's condition since the initial call and to ensure that the replacement products resolved the initial concern; brother states that customer's condition improved.Customer was discharged from the hospital on (b)(6) 2018.Customer is satisfied with the new meter.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.Brother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of vomiting.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.Test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is undisclosed.Brother called in with e-5 error messages as soon as the strip is inserted (8 times).Brother does not wish to troubleshoot further and explained to him that the e-5 means the possibility of his brother's glucose could he elevated.Brother states customer is vomiting and he will call the paramedics and we will follow up in 24 hours.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.Brother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of vomiting.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.Test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is undisclosed.Brother called in with e-5 error messages as soon as the strip is inserted (8 times).Brother does not wish to troubleshoot further and explained to him that the e-5 means the possibility of his brother's glucose could he elevated.Brother states customer is vomiting and he will call the paramedics and we will follow up in 24 hours.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# ((b)(4).Note: manufacturer contacted customer on 5/1/2018 in a follow-up call to ensure the customer's condition since the initial call; customer was admitted to hospital on (b)(6) 2018 for hyperglycemia (blood glucose of 1080mg/dl).Customer had to have urgent dialysis treatment.Customer is blind, has difficulty testing, and lives alone.Therefore, he has not been able to monitor himself and take his insulin properly.Manufacturer contacted customer on a follow-up call to ensure the customer's condition since the initial call and to ensure that the replacement products resolved the initial concern; brother states that customer's condition improved.Customer was discharged from the hospital on (b)(6) 2018.Customer is satisfied with the new meter.

• 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: 7536859
• Report Number: 1000113657-2018-00582
• Device Sequence Number: 19436099
• Product Code: NBW
• UDI-Device Identifier: 00011822590051
• UDI-Public: (01)00011822590051
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 07/10/2018

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: MU2702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/10/2018
• 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; SECOND THERAPY
• Outcome Attributed to Adverse Event: Hospitalization