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

Model Number	STRIP, TTSS MEDI MEDI50CT 24/CS
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Product problem being submitted due to test strips being part of recall #1052693-06/13/16-001-r strip.Truetrack meter and 1 vial of truetrack strips (lot rs4663) were returned, no investigation required: test strips are expired.Note: manufacturer contacted customer in a follow-up call on 11-aug-2021 and customer was sent replacement true metrix system along with envelope to return product to manufacturer.Note: manufacturer contacted customer in a follow-up call on 18-aug-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer.Customer states replacement products resolved customer¿s initial issue.
Event or Problem Description
Consumer reported complaint for dead meter.Customer stated the battery had been changed on (b)(6) 2021.The customer is using the correct battery in the correct orientation for the meter.During the call, the true track meter powered on using the power button and when a test strip was inserted.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.During the call, a back to back blood test was not performed by the customer.The customer's test strips are expired - the test strip lot manufacturer¿s expiration date is 10/25/2017 and test strips are part of recall.

• 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: 12380077
• Report Number: 1000113657-2021-00511
• Device Sequence Number: 11788434
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Recall,Replace,Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 10/25/2017
• Device Model Number: STRIP, TTSS MEDI MEDI50CT 24/CS
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Distributor Facility Aware Date: 07/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1