EMD SERONO EASYPOD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-06 for EMD SERONO EASYPOD manufactured by Emd Serono, Inc..

Event Text Entries

[14866259] Easypod device was malfunctioning. Over the last few days, i have noticed that the device was slow in responding to user prompts, i. E. , when the "remove needle" would pop up, i would click on "ok" and physically remove the needle. But the message would not cancel. In 2009, when i turned the device on, the message "warning" check needle" was stuck on the screen and the device beeped several times with the red light on top staying on. I removed the batteries and put them back in the device several times, to no avail. Message was stuck on the screen and there was no way to delivery medicine. My son missed one dose of saizen, and this sets him back about seven days (per our conversation with his md in the past. I spoke with the nurse from connections for growth who said she would order a replacement device the next day. This device should not lock the medication cartridge inside. There should be a way for the pt to be able to remove the cartridge from the device manually, in case the device is locked or malfunctioning such as what happened to his device on original date. Fortunately, my son still has another cartridge that we can use, so the medication can be delivered manually via an insulin syringe. It appears that the earliest that we can get a replacement device is five days later. This is unacceptable! This device is definitely flawed and should be reviewed. Pts with growth hormone deficiency cannot miss even one dose. Fortunately, i am registered nurse myself, so i can administer the medication via an insulin syringe. I have also noticed that the needle is difficult to remove. Almost daily within the last couple of weeks, i was getting the message "check needle" with the device beeping several times, whenever i would remove the needle. Dose or amount: growth hormone 1 mg, frequency: daily, route: subcutaneously. Dates of use: 2009. Diagnosis or reason for use: growth hormone deficiency.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5012051
MDR Report Key1419349
Date Received2009-07-06
Date of Report2009-07-02
Date of Event2009-07-01
Date Added to Maude2009-07-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEMD SERONO EASYPOD
Generic NameEASYPOD
Product CodeKZE
Date Received2009-07-06
Lot NumberL4-0309 VI
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerEMD SERONO, INC.
Manufacturer AddressROCKLAND MA US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.