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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Codes	Weakness (2145); Dizziness (2194)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-43-environmental testing conditions.Test strip udi# (b)(4).Note: manufacturer contacted customer on 2/12/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved and she did not currently have any diabetic symptoms.No medical intervention was needed since the last call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer initially called for questions and assistance with new truemetrix meter.Back to back control tests performed during call on (b)(6) 2018 were out of range.The customer's expected fasting blood glucose test result range is 112 - 120 mg/dl.At the time of the call the customer reported feeling weak and dizzy; customer did not need medical attention at the time of the call.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The customer stated she just received the test strips on 01/31/2018.Test strip lot manufacturer's expiration date is 06/16/2019 and open vial date is 01/31/2018.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 7285912
• Report Number: 1000113657-2018-00218
• Device Sequence Number: 19362070
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867(17)190616(10)MU2714
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 02/21/2018

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 Expiration Date: 06/16/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1