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

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

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Lancets were not returned for evaluation.Manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for the 33g multi-color trueplus lancets.Customer stated that part of the cap stayed on the surface of the needle after she had removed it; customer stated it was "a piece of plastic chunk." customer is using the product out of this package for the first time and stated that all of the lancets she has used so far have had the same issue.Customer stated that she is not able to lance her finger and she is not able to obtain a blood sample using the lancets.Customer stated the package had not been open or damaged when received.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 12-jul-2022: h6: updated fda¿s type, findings and conclusions codes.H10: lancets were not returned for evaluation.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
• Type of Device: 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: 14621027
• MDR Text Key: 301378115
• Report Number: 1000113657-2022-00319
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 00096295125665
• UDI-Public: 096295125665
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LCT, TP LDR 33G 100CT50/CASE MULTICOLOR
• Device Lot Number: 210701NM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/11/2022
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1