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

Model Number	LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Codes	Product Quality Problem (1506); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the 33g trueplus lancets.Distributor contacted manufacturer on behalf of the customer; distributor internal report reference number: (b)(4) manufacturer contacted customer via telephone.Customer stated that the multi-color lancets had a "big blob" of plastic on the tip and that they are unable to pierce her skin.Customer did not have any of the lancets; customer had returned to pharmacy.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
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure that the initial concern was resolved - able to establish contact with customer who stated the pharmacy had issued her a refund and that she had purchased different lancets.
Additional Manufacturer Narrative
Sections with additional information as of 21-june-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: lancets were not returned for evaluation.Complaint was forwarded to supplier quality based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by the manufacturer.No abnormalities observed on retain samples.Most likely underlying root cause: 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: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 14427530
• Report Number: 1000113657-2022-00285
• Device Sequence Number: 12024426
• Product Code: FMK
• UDI-Device Identifier: 00096295125665
• UDI-Public: 096295125665
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/15/2026
• Device Model Number: LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 210610NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/21/2022
• 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