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	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Customer returned replacement meter - unable to test.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 306, 253 and 311mg/dl.The customer's expected fasting blood glucose test result range is 80 to 100mg/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.The product is stored according to specification.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 107 and 113 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 05/15/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer is calling on behalf of her (b)(6) daughter.Customer's daughter is insulin dependent and tests 3-4 times a day.Customer is getting erratic results on the meter.Point difference is over 30 points.At 07:04:00 pm customer tested her daughter less than 2 hours after dinner and received a reading of 54mg/dl.Customer says at this point she gave her daughter a juice box and waited before testing again.When customer tested again, she received the reading of 135mg/dl.Customer is storing test strips properly, using the correct technique and not using alcohol or any type of hand cleansers.Customer does not have any control solution but was willing to perform back to back blood test on herself.Customer was aware that glucose levels were a bit elevated for fasting results which is why she wanted to ensure meter is functioning properly since close monitoring is recommended for her daughter.
Additional Manufacturer Narrative
(b)(4).Returned strips evaluated with no defect found.Customer returned replacement meter - unable to test.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 306, 253 and 311mg/dl.The customer's expected fasting blood glucose test result range is 80 to 100mg/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.The product is stored according to specification.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 107 and 113 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 05/15/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer is calling on behalf of her (b)(6) daughter.Customer's daughter is insulin dependent and tests 3-4 times a day.Customer is getting erratic results on the meter.Point difference is over 30 points.At 07:04:00 pm customer tested her daughter less than 2 hours after dinner and received a reading of 54mg/dl.Customer says at this point she gave her daughter a juice box and waited before testing again.When customer tested again, she received the reading of 135mg/dl.Customer is storing test strips properly, using the correct technique and not using alcohol or any type of hand cleansers.Customer does not have any control solution but was willing to perform back to back blood test on herself.Customer was aware that glucose levels were a bit elevated for fasting results which is why she wanted to ensure meter is functioning properly since close monitoring is recommended for her daughter.

• 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: 6533835
• Report Number: 1000113657-2017-00763
• Device Sequence Number: 19152244
• Product Code: NBW
• UDI-Device Identifier: 00041415072787
• UDI-Public: (01)00041415072787
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: MT2219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 05/08/2017
• 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