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

Model Number	METRIX AIR
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Customer also stated results have been high but is more concerned with results being erratic.Customer stated that he took medication sometimes because of the results he was getting.The customer is concerned with test results from fasting back to back blood tests of 48 and 131 mg/dl.The customer's expected fasting blood glucose test result is 120 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 kitchen.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (customer is not concerned with fasting results of 48 and 64 mg/dl being low): (b)(6).Customer is concerned with the 48 mg/dl and then 131 mg/dl reading within 15 minutes.Customer says that since the hurricane his readings have been astronomically higher.Customer was more concerned his blood sugar getting erratic results.Customer states he took medication sometimes because of the results he was getting.When customer tested within 15 minutes this morning it went from 48 mg/dl to 131 mg/dl fasting.Customer usually tests his blood sugar after eating and then takes his medication.
Additional Manufacturer Narrative
(b)(4) returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen) test strip (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Customer also stated results have been high but is more concerned with results being erratic.Customer stated that he took medication sometimes because of the results he was getting.The customer is concerned with test results from fasting back to back blood tests of 48 and 131 mg/dl.The customer's expected fasting blood glucose test result is 120 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 kitchen.The test strip lot manufacturer's expiration date is 10/31/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (customer is not concerned with fasting results of 48 and 64 mg/dl being low): (b)(6).Customer is concerned with the 48mg/dl and then 131mg/dl reading within 15 minutes.Customer says that since the hurricane his readings have been astronomically higher.Customer was more concerned his blood sugar getting erratic results.Customer states he took medication sometimes because of the results he was getting.When customer tested within 15 minutes this morning it went from 48mg/dl to 131 mg/dl fasting.Customer usually tests his blood sugar after eating and then takes his medication.

• 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: 7051163
• Report Number: 1000113657-2017-01988
• Device Sequence Number: 16423873
• 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,Followup
• Report Date (Section B): 01/05/2018

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: 10/31/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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