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 Information (3190)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Wrong test strips returned for evaluation.Unable to test the test strips.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) 2018, 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 blood glucose test results accompanied by symptoms.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is unknown.The customer did report symptom of not feeling well.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored according to specification in the bedroom.During the call on (b)(6) 2018, a blood test was performed by the customer and produced test results of 209 and 207mg/dl non-fasting using true metrix air meter.The test strip lot manufacturer's expiration date is 06/21/2019, and open vial date is last month.The meter memory was reviewed for previous test result history.(b)(6) customer states in (b)(6), he does not remember the exact date, he was not feeling well, he states that he went to the clinic to get checked out.There he states that they recommended that he goes to the hospital.He states that there was no treatment at the clinic.Customer states, at the hospital, there were no treatment, no diagnostic, and he was not hospitalized.They only checked his blood sugar.He states that he was told that his results were within range and was not high, he does not remember actual results of meter, the hospital's meter or clinic.Today, the customer is concerned that the meter is reading high.Customer states that he performed a test and got a 401 mg/dl and 310mg/dl fasting.He does not know his expected range, stating that they are all over the place.He requests to have products replace.Customer is feeling well at time of call and no further medical attention is required.

• 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: 8189252
• Report Number: 1000113657-2018-01277
• Device Sequence Number: 13981335
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 12/21/2018

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 Model Number: METRIX AIR
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1