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

Model Number	METRIX AIR
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: user's test strip had poor storage.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Customer was also concerned results were erratic; erratic results under concern were not reported as being performed back to back.The customer is concerned with test results from results obtained of 246, 55 and 187 mg/dl.Customer was concerned that he tested 246 mg/dl and without taking any medication or food he dropped to 55 mg/dl (tests were not within thirty minutes per meter memory).The customer's expected fasting blood glucose test result range is 78 - 110 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 not performed by the customer.The product is not stored according to specification and is stored in the bathroom.The test strip lot manufacturer's expiration date is 08/27/2018 and open vial date was undisclosed.(b)(6).Memory concerns:customer is concerned that he tested 246 mg/dl and in less than one hour without taking any medication or food he dropped to 55 mg/dl.Customer is also concerned that 187 and 246 mg/dl is high.Customer called to report erratic reading on his meter.Customer is also concerned that the results are high.Customer feels fine and denies diabetic symptoms at this time.Customer manages diabetes with insulin and states his last a1c was 6.5 (140 mg/dl).Customer states his normal fasting range is 78-110 mg/dl.Customer is concerned that he tested 246 mg/dl and in less than one hour without taking any medication or food he dropped to 55 mg/dl.Customer is also concerned that 187 and 246 mg/dl is high.Customer stores his supplies in the bathroom, instructed customer on proper storage.
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: user's test strip had poor storage test strip udi#: (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Customer was also concerned results were erratic; erratic results under concern were not reported as being performed back to back.The customer is concerned with test results from results obtained of 246, 55 and 187 mg/dl.Customer was concerned that he tested 246 mg/dl and without taking any medication or food he dropped to 55 mg/dl (tests were not within thirty minutes per meter memory).The customer's expected fasting blood glucose test result range is 78 - 110 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 not performed by the customer.The product is not stored according to specification and is stored in the bathroom.The test strip lot manufacturer's expiration date is 08/27/2018 and open vial date was undisclosed.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns:customer is concerned that he tested 246mg/dl and in less than one hour without taking any medication or food he dropped to 55mg/dl.Customer is also concerned that 187 and 246mg/dl is high.Customer called to report erratic reading on his meter.Customer is also concerned that the results are high.Customer feels fine and denies diabetic symptoms at this time.Customer manages diabetes with insulin and states his last a1c was 6.5 (140mg/dl).Customer states his normal fasting range is 78-110mg/dl.Customer is concerned that he tested 246mg/dl and in less than one hour without taking any medication or food he dropped to 55mg/dl.Customer is also concerned that 187 and 246mg/dl is high.Customer stores his supplies in the bathroom, instructed customer on proper storage.

• 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: 6847153
• Report Number: 1000113657-2017-01677
• Device Sequence Number: 10774312
• Product Code: NBW
• UDI-Device Identifier: 00041220009169
• UDI-Public: (01)00041220009169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/20/2017

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: 08/27/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1