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

Model Number	STRIP, TT 50CT - NOT FORRETAIL SALE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for physical defect of test strips.Customer stated that when he had opened the test strip vial the test strips had been stuck together and that he had to pull them apart.Customer stated that the vial of strips was sealed and intact when received.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 09/15/2023 and open vial date was not disclosed.Customer has discontinued product (truetrack) and was upgraded to true metrix product line.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: customer contacted manufacturer in a follow-up call on 26-jul-2023- customer stated replacement products resolved the initial concern.
Additional Manufacturer Narrative
Sections with additional information as of: 19-sept-2023.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were returned for evaluation.Defect found on returned strips: physical defect of strips: sticking together.Reported defect not reproduced on returned meter.Product evaluation has been completed.Internal investigation has been completed and root cause selected.Root cause: rc-003: other root cause: excessive adhesive on the 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 17479123
• Report Number: 1000113657-2023-00412
• Device Sequence Number: 16793760
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 09/15/2023
• Device Model Number: STRIP, TT 50CT - NOT FORRETAIL SALE
• Device Lot Number: RY5471S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown