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

Model Number	METRIX AIR
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order 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 erratic blood results.The customer is concerned with results obtained of 96 and 173mg/dl.The expected fasting blood glucose test result range is 200mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 4/30/18 and open vial date is approximately one week ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 : 297 mg/dl date: (b)(6) time: 4:06 pm fasting, result 2 : 280 mg/dl date: (b)(6) time: 4:06 pm fasting, result 3 : 96 mg/dl date: (b)(6) time: 12:01 pm fasting , result 4 : 173 mg/dl date: (b)(6) time: 12:01 pm fasting , result 5 : 170 mg/dl date: (b)(6) time: 8:46 pm fasting.Customer states that his blood glucose normally runs high and he is concerned about the back to back results that he performed in which the results were erratic.Date and time not currently set up in the 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: 7010626
• Report Number: 1000113657-2017-01920
• Device Sequence Number: 1006014
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/08/2017

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: MT2190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1