MAUDE Adverse Event Report: TRIVIDIA HEALTH INC LANCET-100; LANCET, BLOOD

Model Number	LCT, TP SMK 30G 100CT24/CASE DK BL
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 19-dec-2024 to ensure the customer¿s initial concern was resolved- the customer is comfortable with the replacement products.
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Customer stated that the needle comes out with the cap.The package was not open or damaged when received by the customer.The customer has used at least half of the box of lancets; customer stated some work and some do not.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 13-feb-2025: h6: updated fda¿s type, findings and conclusions codes.H10: lancets were not returned for evaluation.Complaint was forwarded to supplier quality and internal evaluation was performed by the manufacturer using lancets from the same lot.No abnormalities observed with retention samples.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• Brand Name: LANCET-100
• Common Device Name: LANCET, BLOOD
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: juliana arias ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 21040956
• Report Number: 1000113657-2024-00508
• Device Sequence Number: 8538939
• Product Code: QRK
• UDI-Device Identifier: 00010939701442
• UDI-Public: (01)00010939701442(17)271111(10)220964NM
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220475
• 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): 02/13/2025

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 Model Number: LCT, TP SMK 30G 100CT24/CASE DK BL
• Device Lot Number: 220964NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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