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

Model Number	METRIX AIR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 229 mg/dl.The customer's expected fasting blood glucose test result is 120 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 170 mg/dl and 165 mg/dl using truemetrix air meter.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date at time of call is four weeks.The meter memory was reviewed for previous test result history: result 1 : 192 mg/dl date:(b)(6) 2017 time: 11:34 am fasting, result 2 : 210 mg/dl date: (b)(6) 2017 time: 10:56 am fasting, result 3 : 208 mg/dl date: (b)(6) 2017 time: 8:46 am non-fasting, result 4 : 175 mg/dl date: (b)(6) 2017 time: 3:50 pm non-fasting, result 5 : 229 mg/dl date: (b)(6) 2017 time: 11:30 am fasting.Customer states high blood results.Customer feels well and does not need medical attention.Customer is concerned with high results.Customer is not aware of a1c results.Advised customer to stop using product and return for investigation.Will replace meter , strips, and send two bottles of control solution.

• 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: 7021858
• Report Number: 1000113657-2017-01934
• Device Sequence Number: 16482203
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/10/2017

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 Expiration Date: 10/31/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2459
• 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: 10/18/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1