BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-JECTOR

    MDR report key: 35405 · Received August 7, 1996

    Report

    Report Number
    2182861-1996-00010
    Event Type
    Injury
    Date Received
    August 7, 1996
    Date of Event
    July 29, 1996
    Report Date
    August 6, 1996
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PURCHASED THE DEVICE ON JULY 20, 1996. THEY PRACTISED WITH THE BACTERIOSTATIC SODIUM CHLORIDE PROVIDED. HE HAD WET AND PARTIAL INJECTIONS WITH THE SODIUM CHLORIDE. THEY PROCEEDED TO USE THE DEVICE WITH INSULIN. THEY DID MAKE ADJUSTMENTS TO COMFORT SETTINGS AS ADVISED, BUT WERE UNABLE TO FIND A SETTING THAT GAVE HIM GOOD INJECTIONS. HIS BLOOD GLUCOSE LEVELS ELEVATED AND HE COMPLAINED OF BACK PAIN AND WAS BROUGHT TO THE HOSP ON 7/29. HE WAS ADMITTED TO THE HOSP ON THE FOR 450 BLOOD GLUCOSE LEVELS AND KETONES IN HIS URINE. HE IS CURRENTLY USING SYRINGES AND HAS RETURNED THE DEVICE TO THE STORE FOR A REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECTOR NEEDLE-FREE INSULIN INJECTOR KZE MEDI-JECT CORP. 100430-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization ONE TOUCH HOME GLUCOSE METER| HUMULIN N AND R INSULIN