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

Model Number	TFOCUS
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product, but no evaluation available yet.Most likely underlying root cause: mlc-134-user has low glucose value.Test strip udi#:(b)(4).
Event or Problem Description
Consumer reported complaint for lo display, erratic blood glucose test results.The customer is concerned with erratic tests results from results obtained of 42 and 131mg/dl and meter display of lo.The expected fasting blood glucose test result range is 78-130mg/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 office.During the call a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 08/29/2020 and open vial date is (b)(6) 2019.The meter memory was reviewed for previous test result history.(b)(6).
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report: #: (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-134-user has low glucose value.Test strip udi#: (b)(4).
Event or Problem Description
Consumer reported complaint for lo display, erratic blood glucose test results.The customer is concerned with erratic tests results from results obtained of 42 and 131mg/dl and meter display of lo.The expected fasting blood glucose test result range is 78-130mg/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 office.During the call a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 08/29/2020 and open vial date is (b)(6) 2019.The meter memory was reviewed for previous test result history.Result 1: 131mg/dl, date: (b)(6), time: 10:30pm fasting, result 2: 42mg/dl, date: (b)(6), time: 10:26pm fasting, result 3: 172mg/dl, date: (b)(6), time: 3:16am unknown, result 4: 128mg/dl, date: (b)(6), time: 6:56pm unknown, result 5: lo, date: (b)(6), time: 6:54pm unknown.

• Brand Name: TFOCUS
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8556234
• Report Number: 1000113657-2019-00400
• Device Sequence Number: 14030713
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: TFOCUS
• Device Lot Number: NV1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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.