BEUDAMED
    FDA Adverse Event Other Summary report: N

    MJ7 "VISION" TEST DEVICE

    MDR report key: 243625 · Received October 5, 1999

    Report

    Report Number
    2182861-1999-00003
    Event Type
    Other
    Date Received
    October 5, 1999
    Date of Event
    September 9, 1999
    Report Date
    September 22, 1999
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADMISSION TO ER DUE TO HYPOGLYCEMIA. ON 09/09/1999, HE TOOK HIS USUAL DOSAGE OF 35 UNITS AT 6 A.M. HE WENT TO WORK FEELING THAT HE MAY BE CATCHING THE FLU. HE TOOK TWO TYLENOL. AT 1 P.M. THE AMBULANCE WAS CALLED. UNABLE TO GET A BLOOD GLUCOSE READING. GLUCAGEN WAS GIVEN. ADMITTED TO ER AND OBSERVED FOR TWO HOURS AND RELEASED. HE DID NOT CHECK HIS BLOOD SUGAR ON 09/09/1999. HE ADMITTED THAT HE ONLY CHECKS HIS BLOOD SUGAR EVERY 2-3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MJ7 "VISION" TEST DEVICE NEEDLE-FREE INSULIN DELIVERY SYSTEM KZE MEDI-JECT CORP. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization