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

Model Number	LCT, TP LDR 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	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for the 30g lancets.Complaint was initially reported by distributor via e-mail and customer was contacted via telephone.Customer stated that the needle had come off when he pulled the top off the lancets.The package had not been open or damaged when received.The customer has been using the product out of this package for 2 weeks.Customer is using a competitor's lancing device.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).9 lancets were returned for evaluation.Evaluation in process complaint was forwarded to supplier quality based on complaint's description for investigations.Internal evaluation has been completed by the manufacturer.No abnormalities observed with retention samples.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
Additional Manufacturer Narrative
Sections with additional information as of 22-feb-2023: h3: device evaluated by manufacturer.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: manufacturer's investigation has been completed and root cause selected.No abnormalities observed on returned product, retain samples, and review batch record.All the test results meets the requirements.Most likely underlying root cause: mlc-061: improper use/mishandled by end user.

• 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: 16147140
• Report Number: 1000113657-2023-00015
• Device Sequence Number: 16812334
• Product Code: QRK
• UDI-Device Identifier: 00096295125672
• UDI-Public: (01)00096295125672
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 07/21/2025
• Device Model Number: LCT, TP LDR 30G 100CT50/CASE DK BL
• Device Catalogue Number: 4817912
• Device Lot Number: 200803NM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/22/2023
• 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