BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDI-JECT

    MDR report key: 144739 · Received January 15, 1998

    Report

    Report Number
    2182861-1997-00013
    Event Type
    Other
    Date Received
    January 15, 1998
    Date of Event
    October 28, 1997
    Report Date
    November 10, 1997
    Manufacturer
    MEDI-JECT CORP.
    Product Code
    KZE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER ADMITTED TO HOSPITAL. WAS INITIALLY UNCLEAR WHETHER DUE TO HYPER OR HYPOGLYCEMIA. SAID THAT HIS MEDI-JECTOR WAS NOT WORKING. HE THEN TOLD ME HE TOOK HIS SHOT AND DID NOT EAT BECAUSE HE DID NOT FEEL WELL. LACK OF EATING RESULTED IN HYPOGLYCEMIA. HE DID NOT REMEMBER THE RESULT OF HIS BLOOD GLUCOSE MONITORING BEFORE OR DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-JECT C2-DME-NEEDLE FREE DELIVERY DEVICE KZE MEDI-JECT CORP. 300036-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization