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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Customer returned replacement meter - unable to test.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 (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Husband is calling on behalf of the customer.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 100 to 150mg/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 living room.During the call on (b)(6) 2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is 11/12/2018.The meter memory was reviewed for previous test result history: (b)(6).Customer is concerned that meter is reading high.Customer is storing strips properly and claims to be using the correct testing technique.Customer does not have any control solution to test meter.
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report (b)(4).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 (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Husband is calling on behalf of the customer.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 100 to 150mg/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 living room.During the call on (b)(6) 2018, a blood test was was not performed by the customer.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is 11/12/2018.The meter memory was reviewed for previous test result history: result 1:182mg/dl date:(b)(6) 2018, time:11:38am fasting, result 2:174mg/dl date:(b)(6) 2018, time:6:05pm fasting, result 3:180mg/dl date:(b)(6) 2018, time:9:22pm fasting, result 4:158mg/dl date:(b)(6) 2018, time::33pm fasting, result 5:163mg/dl date:(b)(6) 2018, time:3:32pm fasting, result 6:211mg/dl date:(b)(6) 2018, time:11:10am fasting.Customer is concerned that meter is reading high.Customer is storing strips properly and claims to be using the correct testing technique.Customer does not have any control solution to test meter.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8135647
• Report Number: 1000113657-2018-01219
• Device Sequence Number: 11192847
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• PMA/510(K) Number: K140100
• 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): 01/09/2019

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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