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	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi#: (b)(4).Note: manufacturer contacted customer on (b)(6) 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 hi display.Friend is calling on behalf of the customer.The expected fasting blood glucose test result range is 150 to 200mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of 286 and 295mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 09/16/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history.(b)(6).At the time of the call customer states she was hospitalized in (b)(6) or (b)(6) of 2017.Customer states that went to the hospital due to neck pain, fast pulse, and feet cramped.Customer was told that her sugar was in the 300's and was dehydrated.Customer received iv fluids and dextrose.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 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 hi display.Friend is calling on behalf of the customer.The expected fasting blood glucose test result range is 150 to 200mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on 11/20/2018, a blood test was performed by the customer and produced test results of 286 and 295mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 09/16/2019 and open vial date is 10/20/18.The meter memory was reviewed for previous test result history.Result 1:305mg/dl, date: (b)(6) 2018, time:12:11pm, fasting; result 2:354mg/dl, date: (b)(6) 2018, time:12:03pm, fasting; result 3:250mg/dl, date: (b)(6) 2018, time:11:54am, fasting; result 4:255mg/dl, date: (b)(6) 2018, time:7:54am, fasting; result 5:254mg/dl, date: (b)(6) 2018, time:10:36am, fasting; result 6:hi, date: (b)(6) 2018, time:5:01pm, non-fasting.At the time of the call customer states she was hospitalized in (b)(6) of 2017.Customer states that went to the hospital due to neck pain, fast pulse, and feet cramped.Customer was told that her sugar was in the 300's and was dehydrated.Customer received iv fluids and dextrose.

• 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: 8162585
• Report Number: 1000113657-2018-01247
• Device Sequence Number: 1697557
• Product Code: NBW
• UDI-Device Identifier: 00087701427398
• UDI-Public: (01)00087701427398
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 01/03/2019

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: MV2822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY; SECOND THERAPY