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

Model Number PEN NEEDLE

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

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

Event Date 12/07/2018

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 inaccurate dispense/ aspiration and pen needle not aligning with a compilable pen needle injector.The customer feels well and did not report any symptoms.Customer does not have original true plus pen needle box to provide lot number.Customer stated she threw away the box and she did state pen needles have a purple cover.Customer did not claim she was injured while using the product nor did she have a negative reaction to the product.Customer did not claim she was stuck with the needle or that the needle was out of protective cover.Customer did not have to seek medical attention at a previous time due to concerns of product being unable to administer insulin.Customer did not have any concerns that the product needle is bent or broken.Customer did not have any concerns the products are discolored, or appearance is not as designed.

Manufacturer Narrative

(manufacturer narrative = t, corrected data = f) internal report # 01608309 product returned evaluation.Qc investigation on 2/5/2019 result in defect found.Visually inspected returned pen needles (4).Pen needles arrived without protective seal and with inner component bent: can not align or dispense properly.Defect found.Final root cause: rc-041-user/mechanical stress 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 inaccurate dispense/ aspiration and pen needle not aligning with a compliable pen needle injector.The customer feels well and did not report any symptoms.Customer does not have original true plus pen needle box to provide lot number.Customer stated she threw away the box and she did state pen needles have a purple cover.Customer did not claim she was injured while using the product nor did she have a negative reaction to the product.Customer did not claim she was stuck with the needle or that the needle was out of protective cover.Customer did not have to seek medical attention at a previous time due to concerns of product being unable to adminster insulin.Customer did not have any concerns that the product needle is bent or broken.Customer did not have any concerns the products are discolored, or appearance is not as designed.

• Brand Name: PEN NEEDLE
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8201149
• MDR Text Key: 131913424
• Report Number: 1000113657-2018-01295
• 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: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY; SECOND THERAPY