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

Model Number STRIP, WALGREENS 100CTTT #673261

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips (2 vials) were returned - product evaluation in-process.Manufacturer contacted customer in a follow-up call on 02-mar-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for physical defect of test strips.Customer stated that the test strips are stuck together.Customer stated that she purchased two vials of test strips on (b)(6) 2022 (same lot number); only one of the vials has been opened by the customer.Customer stated that the test strips that were sticking do not work.The test strip lot manufacturer¿s expiration date is 07/31/2023.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.

Manufacturer Narrative

Sections with additional information as of 08-april-2022 h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and test strips (2 vials) were returned -defect found on returned strips: physical defects of strips- strips stuck together and control results out of range.Reported defect not reproduced on returned meter.Product evaluation has been completed.Returned product was forwarded to r&d chemistry for root-cause.R&d investigation has been completed root causes selected.Retention strips tested within 6 months passed within specifications.Root cause: rc-003: other root cause: (excess of adhesive on the strips) and rc-061: storage outside specifications.

• Brand Name: TRUETRACK
• Type of Device: 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: 13847671
• MDR Text Key: 297792188
• Report Number: 1000113657-2022-00154
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: STRIP, WALGREENS 100CTTT #673261
• Device Catalogue Number: A4H01-81
• Device Lot Number: RY5465S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/22/2022
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/22/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1