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

Model Number	METRIX AIR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-134-user has low 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 low blood glucose results.The customer is concerned with results obtained of 75, 79.64 and 66mg/dl.Expected fasting blood glucose test result range is 80-100mg/dl.The customer did report symptoms of low blood sugar (not specified) on previous events.Customer felt well at the time of the call.Medical attention not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the kitchen.During the call on (b)(6) 2018, a back to back blood test was not performed by customer.The test strip lot manufacturer's expiration date is 10/16/2019 and open vial date is one week ago.The meter memory was reviewed for previous test result history:(time and date is not correct in the meter) (b)(6).Customer stated that when she is getting low result she feels symptoms of low.Customer has gone to the doctor's office several times and compared meter to meter and with our meter, the readings were 70 and below and with their meter reading were in the 80-90mg/dl within 5 to 10 mins.Customer also went to the hospital due to our meter.Customer was having symptoms of low and tested with our meter results in the 60's, customer stated she treated the symptoms by eating pizza and other things.When she arrived at the hospital her readings were in the 70's again (within 15 minutes).Customer was only given food for treatment and sent home the same day.No medical treatment was provided to the customer.Customer has not been diagnosis with hypoglycemia.Customer is currently not feeling any symptoms at the moment.Customer continued to test with our meter and results were still low readings.

• 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: 7942797
• Report Number: 1000113657-2018-01008
• Device Sequence Number: 11178790
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2857
• 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: 09/12/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1