MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. PEN NEEDLE; BLOOD GLUCOSE SYSTEM

Model Number PEN NEEDLE

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-61- improper use / mishandled by end user.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.

Event Description

Consumer reported complaint for pen needle not aligning with compilable pen needle injector.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The pen needle lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.Pharmacy tech call and states that the patient still has the pen needles.Patient uses the needle he put the protect cover on the needle will not aligning, he is unable to get the pen needle off.He states that distributor will not reimburse the product back to him because he did not receive the product defective.He wants us to contact the distributor to replace the product for him or to offer him credit and he will then replace the product for the patient.

• Brand Name: PEN NEEDLE
• Type of Device: BLOOD GLUCOSE SYSTEM
• 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 ; 954677-920
• MDR Report Key: 8143525
• MDR Text Key: 130051423
• Report Number: 1000113657-2018-01234
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K143437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/07/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: PEN NEEDLE
• Device Lot Number: X56S7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1