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

Model Number	KIT, TTSS METER
Medical Device Problem Codes	Failure to Power Up (1476); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2020
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.Meter and test strips were not returned to manufacturer.Root cause: rc-074: manufacturing processing error.Manufacturer acknowledges the lateness of this report and initiated the necessary corrective action.Manufacturer corrective action number: capa (b)(4).
Event or Problem Description
Consumer reported complaint for dead meter.Daughter is calling on behalf of the customer.The battery in the true track meter had been changed (b)(6) 2020.The customer is using the correct battery for the meter in the correct orientation.During the call, the true track meter powered on using the power button and when a test strip was inserted.The test strips are expired - manufacturer's expiration date is 02/28/2017 and test strips are part of recall.Daughter stated that customer will purchase new test strips.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

• 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: 12487806
• Report Number: 1000113657-2021-00576
• Device Sequence Number: 19107766
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: 02/28/2017
• Device Model Number: KIT, TTSS METER
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4521
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1