MAUDE Adverse Event Report: PFIZER GENOTROPIN MINIQUICK

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 09/06/2006

Event Type  malfunction  

Event Description

Patient reported that when she tried to use a genotropin 0.8mg miniquick that the device malfunctioned and would not push the medication through.Dose or amount: 0.8 mg/milligrams.Frequency: other.Route: subcutaneous.Therapy start date: (b)(6) 2015.Therapy end date: (b)(6) 2016.Therapy duration: na.Diagnosis or reason for use: growth hormone.Event abated after use stopped or dose reduced: doesn't apply.Event reappeared after reintroduction: doesn't apply.

• Brand Name: GENOTROPIN MINIQUICK
• Type of Device: GENOTROPIN MINIQUICK
• Manufacturer (Section D): PFIZER
• MDR Report Key: 5942475
• MDR Text Key: 54509911
• Report Number: MW5064655
• Device Sequence Number: 1
• Product Code: NSC
• UDI-Device Identifier: 00013265202
• UDI-Public: 00013-2652-02
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR