BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-JECTOR VISION

    MDR report key: 276650 · Received May 5, 2000

    Report

    Report Number
    2182861-2000-00003
    Event Type
    Other
    Date Received
    May 5, 2000
    Date of Event
    April 13, 2000
    Report Date
    May 3, 2000
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT'S BLOOD GLUCOSE WAS 17. PARAMEDICS WERE CALLED AND WERE ABLE TO BRING PT'S BLOOD SUGAR UP TO AN ACCEPTABLE LEVEL. PT STATED PT DID NOT EAT WELL THAT DAY AND WAS INCREASING PT'S PHYSICAL ACTIVITY AS A RESULT OF HAVING JUST STARTED A NEW JOB. PT HAS HAD PROBLEMS WITH CONTROL WHILE USING A NEEDLE & SYRINGE, ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECTOR VISION NEEDLE-FREE INJECTOR KZE MEDI-JECT CORP. 300035-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening