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

Model Number	STRIP, WALGREENS 50CT TT#673239
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2019
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
(b)(6) husband is calling on behalf of customer to get assistance with the meter and running a blood test.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: 07/31/2017.Customer test strips have been affected by the recall.Customer will purchase new 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
• MDR Report Key: 12495372
• Report Number: 1000113657-2021-00595
• Device Sequence Number: 1348617
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: 07/31/2017
• Device Model Number: STRIP, WALGREENS 50CT TT#673239
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4608
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1