BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITROPE PEN 5

    MDR report key: 18486938 · Received January 9, 2024

    Report

    Report Number
    MW5150094
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    July 7, 2023
    Report Date
    January 5, 2024
    Manufacturer
    SANDOZ INC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY SON IS ON A GROWTH HORMONE TREATMENT. HE IS 12 YEARS OLD NOW AND HAS BEEN USING OMNITROPE 5MG CARTRIDGES FOR INJECTIONS SINCE HE WAS 8 OR 9 YEARS OLD. IN (B)(6) OF 2023 HIS DOSAGE CHANGED, AND HE WAS PUT ON OMITROPE 10MG CARTRIDGES. PHARMACY SHIPPED US THE NEW MEDICATION WITHOUT SENDING US THE NEW INJECTION PEN THAT GOES WITH IT. THE 10MG CARTRIDGES FIT IN THE OLD 5MG INJECTIONS PENS AND LOOKS ALMOST IDENTICAL. UNKNOWINGLY MY SON WAS USING THE 5MG PEN WHICH WAS DISPENSING DOUBLE AS MUCH AS PRESCRIBED. WE ONLY FOUND OUT OF THE PROBLEM BECAUSE WE NOTICED THAT MY SON RUNS OUT OF MEDICATION QUICKER THAN USUAL BUT PHARMACY WAS HAPPY TO REFILL 10MG CARTRIDGES CAN BE PLACED IN THE 5MG PENS (WHICH CAN CAUSE OVERDOSING). IN SUMMARY, 1) 10MG AND 5MG OMNITROPE CARTRIDGES LOOK ALMOST IDENTICAL. 2) 10MG AND 5MG INJECTION PENS LOOK VERY SIMILAR WITH NO WARNING LABELS. 3) PHARMACY SHIPS PRODUCTS WITHOUT PENS. 4) PEN IS PRESCRIBED SEPARATELY AND IS PRODUCED BY A DIFFERENT COMPANY. 5) PHARMACY SHIPS PRODUCTS MORE THAN NEEDED SO YOU CAN OVERDOSE AND STILL HAVE ENOUGH MEDICATION. 6) DR. OFFICE DIDN'T COMMUNICATE WELL ENOUGH ABOUT THIS IMPORTANT CHANGE TO MY SON'S MEDICATION. 7) MANUFACTURER NEVER SENT OUT THE NEW 10MG PEN TO US. I CAN SEE HOW WHAT HAPPENED TO MY SON CAN HAPPEN TO A LOT OF PEOPLE USING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676100 OMNITROPE PEN 5 INJECTOR, PEN NSC SANDOZ INC. 2162012

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other