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	Shaking/Tremors (2515)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report (b)(4).Returned meter evaluated with no defect found.Test strips not 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).
Event or Problem Description
Consumer reported complaint for low blood glucose results accompanied by symptoms.Arin, caretaker, is calling on behalf of the customer.The customer is concerned with meter to meter comparison results using the true metrix air of 221mg/dl and 279 using the doctor's meter.The expected fasting blood glucose test result range is 180-190mg/dl.The customer did report symptoms of feeling shaky and having difficulty seeing and hearing.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 in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 215 and 226mg/dl using metrix air meter.The test strip lot manufacturer's expiration date is 02/28/2019 and open vial date was last week.The meter memory was reviewed for previous test result history: (b)(6).Her results of concerned is 221mg/dl fasting with true metrix and doctor's office meter 279mg/dl fasting.Customer went to the doctor's office on (b)(6) 2017 because she felt like she was going into a diabetic coma.Customer states she was shacking and could not hear or see.At the doctor's office, her blood sugar was 279mg/dl with their meter and the true metrix read 221mg/dl.Customer is concerned with the differences in points and does not trust the meter.No new medications were administered and customer was send home the same day.Customer does not have a diagnosis.Customer feels well at the time of call and no medical attention is required.

• 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: 7145691
• Report Number: 1000113657-2017-02110
• Device Sequence Number: 927218
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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: MU2608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1