FDA Adverse Event Malfunction Summary report: N

EMD SERONO EASYPOD

MDR report key: 1419349 · Received July 6, 2009

Report

Report Number
MW5012051
Event Type
Malfunction
Date Received
July 6, 2009
Date of Event
July 1, 2009
Report Date
July 2, 2009
Manufacturer
EMD SERONO, INC.
Product Code
KZE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EMD SERONO EASYPOD EASYPOD KZE EMD SERONO, INC. L4-0309 VI

Patients

Seq Age Sex Outcome Treatment
1 7 YR SAIZEN 1 MG IS THE MEDICATION THAT IS ADMINISTERED| VIA EASYPOD.