MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE PLUS LANCETS; LANCET, BLOOD

Model Number	LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
Medical Device Problem Codes	Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Lancets were not returned for evaluation.Note: manufacturer contacted customer in several follow-up e-mails to ensure that the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint via e-mail for the trueplus 33g lancets.Customer stated that she had experienced pain after using the lancet, and that the lancet had two needles (double needle).Customer also stated that a few weeks prior one of the lancets had been missing the needle.No medical intervention related to the use of the product was reported.Customer did not provide contact telephone number; email response had been sent to customer.
Additional Manufacturer Narrative
Sections with additional information as of 05-oct-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: lancets were not returned for investigation.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, reported defect not reproduced on retention samples added most likely underlying root cause: mlc-009-use error caused or contributed to event.

• Brand Name: TRUE PLUS LANCETS
• Common Device Name: LANCET, BLOOD
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 12384751
• Report Number: 1000113657-2021-00520
• Device Sequence Number: 3528289
• Product Code: FMK
• UDI-Device Identifier: 00021292004484
• UDI-Public: 021292004484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 06/18/2025
• Device Model Number: LCT, TP NPD 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 200572NM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/05/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1