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	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: mlc-20 user's test strip had poor storage.(kitchen).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the result obtained.The expected fasting blood glucose test result range is 99 to 150mg/dl.The customer did not report symptoms.Customer did bring meter to the doctor as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017, a back to back blood test was performed or non-fasting by the customer and produced test results of 137 and 118 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 03/17/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) 168mg/dl (b)(6) 2017 11:36 am fasting: yes; 160mg/dl (b)(6) 2017 11:06 am fasting: yes; 203mg/dl (b)(6) 2017 08:53 am fasting: yes; 125mg/dl (b)(6) 2017 08:09 pm fasting: no; 189mg/dl (b)(6) 2017 10:46 am fasting: yes.Memory concerns: customer is concerned with all of the readings.Customer called regarding high results.Customer states that since he was upgraded from true result to true metrix meter, readings have been 50-60 points higher.Customer says he still believes results are much higher than expected.Customer says, because the meter was reading high, he went in to see his doctor on (b)(6) 2017.Customer says according to his doctor, blood glucose result was 81mg/dl.Customer says when he went home shortly after, and is not sure of exact time between readings, he tested with true metrix meter and result was 68 points higher.Customer is storing test strips in kitchen but says it is in a cool area.Advised on proper storage.Customer does not have any control solution.
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 of malfunction: mlc-20 user's test strip had poor storage.(kitchen) test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the result obtained.The expected fasting blood glucose test result range is 99 to 150mg/dl.The customer did not report symptoms.Customer did bring meter to the doctor as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017, a back to back blood test was performed or non-fasting by the customer and produced test results of 137 and 118 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 03/17/2018 and open vial date is 3/1/2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Memory concerns: customer is concerned with all of the readings.Customer called regarding high results.Customer states that since he was upgraded from true result to true metrix meter, readings have been 50-60 points higher.Customer says he still believes results are much higher than expected.Customer says, because the meter was reading high, he went in to see his doctor on (b)(6) 2017.Customer says according to his doctor, blood glucose result was 81mg/dl.Customer says when he went home shortly after, and is not sure of exact time between readings, he tested with true metrix meter and result was 68 points higher.Customer is storing test strips in kitchen but says it is in a cool area.Advised on proper storage.Customer does not have any 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: 6728685
• Report Number: 1000113657-2017-01454
• Device Sequence Number: 653023
• Product Code: NBW
• UDI-Device Identifier: 00010939742445
• UDI-Public: (01)00010939742445
• 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,Followup
• Report Date (Section B): 08/17/2017

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: MT1964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1