BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-FECTOR

    MDR report key: 187894 · Received September 18, 1998

    Report

    Report Number
    2182861-1998-00005
    Event Type
    Other
    Date Received
    September 18, 1998
    Date of Event
    July 15, 1998
    Report Date
    July 23, 1998
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADMITTED TO HOSP WITH DIABETIC KETOACIDOSIS. BLOOD SUGAR ELEVATED TO 584. HOSPITALIZED 4 DAYS. NURSE NOTICED THE REGULAR INSULIN WAS CLOWDY; QUESTIONING PROPER USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-FECTOR NEEDLE FREE DELIVERY SYSTEM KZE MEDI-JECT CORP. 100265-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization