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

Model Number	LCT, TP NPD 30G 100CT50/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	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were returned - product evaluation in-process.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for the trueplus lancets.Customer stated that when she twists the circle top of the lancet and pulls it out, the whole needle comes easily out of the plastic body part; per customer the needle is stuck inside of the circle twist top.Customer stated she does not get stuck by the needle as it is not exposed since its still inside of the twist top.Customer stated this has occurred 4 times.Per customer she started using this box of lancets on (b)(6) 2026.The customer feels well and did not report any symptoms.Customer did not claim to be injured while using the lancets and no medical intervention related to the use of the product was reported.
Additional Manufacturer Narrative
Sections with additional information as of 06-apr-2026: h3: was the device evaluated by the manufacturer and if the device was not evaluated, select from the approved fda codes or select 'other' and enter text in h10.H6: updated fda¿s type, findings and conclusions codes.H10: lancets were returned.Unable to ship returned lancets to manufacturer due to biohazard.Return product scrapped.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-009: use error caused or contributed to event.

• 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: 24559157
• Report Number: 1000113657-2026-00099
• Device Sequence Number: 9495587
• Product Code: QRK
• UDI-Device Identifier: 00021292004460
• UDI-Public: (01)00021292004460(17)300604(10)250505NM
• Combination Product (Y/N): N
• 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): 04/06/2026

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 NPD 30G 100CT50/CASE DK BL
• Device Lot Number: 250505NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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