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

Model Number LCT, TP NPD 33G 100CT50/CASE MULTICOLOR

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pain (1994)

Event Date 08/05/2021

Event Type  Injury  

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 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.

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
• Type of Device: LANCET, BLOOD
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 12384751
• MDR Text Key: 268704872
• Report Number: 1000113657-2021-00520
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 00021292004484
• UDI-Public: 021292004484
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1