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

Model Number	STRIP, WALGREENS 100CTTT #673261
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer called to inquire about product - daughter is calling on behalf of the customer.Customer has discontinued product - customer has true track meter and test strips.The test strips are expired - manufacturer's expiration date is 10/31/2017 and test strips are part of recall.Customer did not report a complaint associated with the products.The customer feels well and did not report any symptoms.No medical attention associated with the use of the products was reported.Customer has different brand meter and test strips she will be using.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).B1: product problem being submitted due to test strips being part of recall # 1052693-06/13/16-001-r strip.Meter and test strips were returned, no investigation required: test strips are expired and no product complaint was alleged by the customer.Root cause: rc-074: manufacturing processing error.Note: manufacturer contacted customer in a follow-up call on 12-jun-2023 to ensure the initial concern has been resolved - able to establish contact with customer who stated they will be using a different brand meter and strips.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 17204174
• Report Number: 1000113657-2023-00343
• Device Sequence Number: 5768485
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 10/31/2017
• Device Model Number: STRIP, WALGREENS 100CTTT #673261
• Device Lot Number: RS4670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Distributor Facility Aware Date: 06/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown