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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2019
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 strips were not returned to manufacturer.Customer did not allege a product defect.Root cause: rc-074-manufacturer-processing error.Manufacturer acknowledges the lateness of this report and initiated the necessary corrective action.Manufacturer corrective action number: (b)(4).
Event or Problem Description
Mother calling on behalf of customer for assistance with meter and strips.Advised caller that the test strips are expired, and to discard and purchase new track test strips.Customer did not allege a product defect.Customer did not report symptoms.Medical attention with use of product was not reported.The test strips are expired: 09/13/2017.Customer test strips have been affected by the 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: 12506138
• Report Number: 1000113657-2021-00603
• Device Sequence Number: 16497898
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• 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): 09/21/2021

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: 09/13/2017
• Device Model Number: KIT, TT STARTER NOT FORRETAIL SALE
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4631
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1