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

Model Number METRIX AIR

Device Problem High Test Results (2457)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Weakness (2145)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call and that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.A product letter was send to the customer to contact customer care for further assistance.

Event Description

Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 110 to 125mg/dl.The customer did report symptoms of feeling weak which caused her to fall and break her clavicle bone.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.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 111 and 104 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is within the month of september 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) (b)(6).Memory concerns: results recorded from patient manual log.On (b)(6) 2017 patient, (b)(6) female, felt she was experiencing hypoglycemia; however, meter results were reading high.Customer states she felt weakness, which caused her to fall and fracture her clavicle.Customer sought treatment at (b)(6) where she only received x-rays during her visit with a diagnosis of acute fracture on tip of clavicle.Patient states she did not receive treatment in relation to her diabetes she did not mention it to healthcare staff.She was discharged that same day and is awaiting follow up to determine if surgery will be required to repair the fracture.At this time, patient states her clavicle is still sticking up.

• 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: 6910540
• MDR Text Key: 88051994
• Report Number: 1000113657-2017-01767
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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: MU2465
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 09/06/2017
• 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
• Treatment: SECOND THERAPY