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

Model Number	METRIX AIR
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2019, in a follow-up call 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 or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high and low blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with high tests results from results obtained of294 and 236mg/dl and low results obtained of 89mg/dl.The expected fasting blood glucose test result range is 120 to 180mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on (b)(6) 2019, a blood test was not performed by the customer and produced test results of 245 and 281mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 02/24/2020, and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6).
Event or Problem Description
Consumer reported complaint for high and low blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with high tests results from results obtained of 294 and 236mg/dl and low results obtained of 89mg/dl.The expected fasting blood glucose test result range is 120 to 180mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call on (b)(6) 2019, a blood test was not performed by the customer and produced test results of 245 and 281mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 02/24/2020 and open vial date is 12/02/2018.The meter memory was reviewed for previous test result history: result 1:236mg/dl, date: (b)(6) 2019, time:11:05am, fasting.Result 2:294mg/dl, date: (b)(6) 2018, time:11:25am, fasting.Result 3:89mg/dl, date: (b)(6) 2018, time:10:21am, fasting.Result 4:281mg/dl, date: (b)(6) 2019, time:3:14pm, not fasting.Result 5:245mg/dl, date: (b)(6) 201,9 time:3:11pm, not fasting.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01612180 returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).Note: manufacturer contacted customer on 1/09/2019 in a follow-up call 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 or symptoms since the last call.

• 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: 8274110
• Report Number: 1000113657-2019-00061
• Device Sequence Number: 13779691
• Product Code: NBW
• UDI-Device Identifier: 00311917173894
• UDI-Public: (01)00311917173894
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/15/2019

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: MV2907S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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