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	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on (b)(6) 2018 resulted in defect found; returned test strips produce high readings and the event was determined to be reportable.Most likely underlying root cause of high readings are due to improper storage: vial left open for an extended period of time (b)(4).Manufacturer contacted customer on 1/26/2018 in a follow-up call in order 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 since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Son is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 95 mg/dl.Customer stated they had felt sick and felt like their blood sugar should have been lower.The customer's expected fasting blood glucose test result is 110 mg/dl.During the call on (b)(6) 2018 the customer felt well and did not report any symptoms.Medical intervention is not reported at the time of the call on (b)(6) 2018 as a result of the meter's readings.Customer stated results obtained using truemetrix air meter were higher than another device; actual meter to meter comparison results were not provided.During the call on (b)(6) 2018, 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 (b)(6) 2018 and open vial date at time of call was two weeks.Customer stated results obtained (b)(6) 2018 were obtained using a different vial of test strips with the same lot number that had been stored correctly; customer was not concerned with those results stating that they were accurate.The meter memory was reviewed for previous test result history: result 1 :160mg/dl date: (b)(6) 2018 time:11:25am fasting, result 2 :172mg/dl date: (b)(6) 2017 time:7:17am fasting, result 3 :167mg/dl date: (b)(6) 2017 time:5:26am fasting, result 4 :97mg/dl date: (b)(6) 2017 time:12:20am fasting, result 5 :94mg/dl date:(b)(6) 2017 time:7:45 pm fasting.

• 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: 7284176
• Report Number: 1000113657-2018-00213
• Device Sequence Number: 1176944
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• 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
• Report Date (Section B): 02/20/2018

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: 12/31/2018
• Device Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MU2541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1