BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTARES PHARMA

    MDR report key: 445898 · Received December 17, 2002

    Report

    Report Number
    MW4003452
    Event Type
    Injury
    Date Received
    December 17, 2002
    Report Date
    December 17, 2002
    Manufacturer
    ANTARES PHARMA, INC
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED TO SOMEONE IN THE FDA (EITHER LOCAL, STATE OR FEDERAL) THAT THEY WERE HAVING TROUBLE WITH THEIR INSULIN INJECTOR. PT'S INSULIN INJECTOR IS A MEDO-JECT (AN NEEDLE FREE INJECTION SYSTEM). PT SAID THAT THEY HAD DRUG RUNNING DOWN THEIR LEG, SO THEY COULD NOT TELL HOW MUCH DRUG THEY WERE ACTUALLY INJECTING. PT SAID THAT THEY HAD A DIABETIC SEIZURE WHILE USING THE PRODUCT DUE TO THEIR INSULIN LEVEL. PT CALLED MEDI-JECT (COMPANY IS ANTARES PHARMA) AND THEY WERE NOTIFIED OF A PRODUCT RECALL. THE COMPANY INFORMED PT THAT THE REASON FOR THE RECALL WAS THAT THE TRIGGER MECHANISM CAUSED AN IMPROPER DOSAGE OF INSULIN TO BE INJECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTARES PHARMA MEDI-JECT LZG ANTARES PHARMA, INC * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *