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	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 5/10/2018 returned test strips produce high readings.Most likely underlying root cause of high readings are due to improper storage: strips left outside of vial for an extended period of time.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from meter to meter comparison of 164 mg/dl using truemetrix air meter and 126 mg/dl using another device, and from results obtained of 246 and 275 mg/dl.The customer's expected fasting blood glucose test result range is 140 - 160 mg/dl.Customer also stated that at a routine doctor's appointment, the truemetrix air meter read higher than the doctor's meter; actual meter to meter comparison results were not provided.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.Customer was advised of proper testing technique and not to use alcohol pads.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 135 mg/dl and 136 mg/dl using truemetrix air meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 06/19/2018 and open vial date is a few days at time of call.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 7535121
• Report Number: 1000113657-2018-00578
• Device Sequence Number: 10821287
• Product Code: NBW
• UDI-Device Identifier: 00021292007911
• UDI-Public: (01)00021292007911
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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 Expiration Date: 06/19/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1