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	03/07/2018
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).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 90 to 116 mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was performed non-fasting by the customer and produced test results of 104 and 104 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 3/31/19 and open vial date is a month and a half ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly): (b)(6).Customer is concerned with the high results that he is getting from his meter.Customer stated that he went to the doctor yesterday and was advised that his a1c was 6.5 and the doctor tested his blood glucose on his meter (customer did not know what the result from his doctor's meter was) and tested himself on his meter and the results were around 25 points off.Customer did not set up the time in the meter when he received it.
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.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.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 90 to 116mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was performed non-fasting by the customer and produced test results of 104 and 104mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 3/31/19 and open vial date is a month and a half ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Customer is concerned with the high results that he is getting from his meter.Customer stated that he went to the doctor yesterday and was advised that his a1c was 6.5 and the doctor tested his blood glucose on his meter (customer did not know what the result from his doctor's meter was) and tested himself on his meter and the results were around 25 points off.Customer did not set up the time in the meter when he received it.

• 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: 7390826
• Report Number: 1000113657-2018-00389
• Device Sequence Number: 10958893
• Product Code: NBW
• UDI-Device Identifier: 00052569139042
• UDI-Public: (01)00052569139042
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/06/2018

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: MU2636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/06/2018
• 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