BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-JECTOR CHOICE

    MDR report key: 208253 · Received January 29, 1999

    Report

    Report Number
    2182861-1999-00001
    Event Type
    Other
    Date Received
    January 29, 1999
    Date of Event
    December 26, 1998
    Report Date
    January 7, 1999
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO INTENSIVE CARE UNIT BECAUSE OF DIABETIC KETOACIDOSIS. HER SERUM GLUCOSE WAS GREATER THAN 500. SHE HAD RED BLOTCHES ON HER SKIN. SHE STATES THAT "98% OF HER INJECTIONS WERE 'WET' INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM KZE MEDI-JECT CORP. 300036-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization