MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUETRACK; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	KIT, TT STARTER NOT FORRETAIL SALE
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation; defect found: defective lcd display/partial characters.Test strips were not returned for evaluation.Most likely, underlying root cause: rc-026: meter displays partial characters due to user mechanical stress.The meter does not produce an e-4 or partial e-4 when running a blood glucose test.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020, to ensure the replacement products resolved the initial concern.I was able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for defective lcd display/partial characters.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms, and no medical attention was reported as a result.The product storage location is undisclosed.The test strip lot manufacturer¿s expiration date is 03/31/2022, and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUETRACK
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10626780
• Report Number: 1000113657-2020-00724
• Device Sequence Number: 2438660
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• 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): 10/05/2020

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: 03/31/2022
• Device Model Number: KIT, TT STARTER NOT FORRETAIL SALE
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5385S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Distributor Facility Aware Date: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1