MAUDE Adverse Event Report: CARTRIDGE; SYRINGE, CARTRIDGE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/28/2017

Event Type  malfunction  

Event Description

Pt stated that cartridge malfunctioned and pt was not able to give dosage.Prescriber and mfr are aware.Pt will continue on medication.Dose or amount: 100mcg, frequency: daily, route: subcutaneously.Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: hypoparathyroidism.Reported to (b)(6) by: pt/caregiver.Physician name: (b)(6).

• Brand Name: CARTRIDGE
• Type of Device: SYRINGE, CARTRIDGE
• MDR Report Key: 7002947
• MDR Text Key: 91205087
• Report Number: MW5073151
• Device Sequence Number: 1
• Product Code: EJI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR