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

Model Number METRIX AIR

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Swelling (2091)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-78- user hematocrit low.Test strip udi# (b)(4).Note: manufacturer contacted customer on 3/13/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer is admitted to the hospital as of (b)(4) 2018.Nurse is unsure if customer is still experiencing symptoms and the diagnosis.Unable to reach the customer after several follow up attempts.

Event Description

Consumer reported complaint for e-0 accompanied by symptoms.Nurse is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of swollen face.Medical attention is reported as a result of reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 06/27/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Meter reads e-0 once the blood is absorbed.Nurse states the customer has swelling on the right side of the face is going to send the customer to the hospital.Nurse does not know if it is due to diabetes.Nurse cannot troubleshoot at this time.

• Brand Name: METRIX AIR
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 7392532
• MDR Text Key: 104558573
• Report Number: 1000113657-2018-00394
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2725
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization