BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 509002 · Received January 29, 2004

    Report

    Report Number
    1819470-2004-00003
    Event Type
    Injury
    Date Received
    January 29, 2004
    Report Date
    January 5, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY A CONSUMER WHO INITIALLY CONTACTED THE AFFILIATE REQUESTING MEDICAL INFORMATION, CONCERNS A PT OF UNKNOWN AGE. THE PT RECEIVED SUBCUTANEOUS HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN REGULAR INSULIN 30% (HUMACART 3/7) VIA A HUMAPEN ERGO (LOT# UNKNOWN) WITH OPAQUE (BLUE) CARTRIDGE HOLDER ATTACHED (DOSE, INDICATION AND START DATE NOT PROVIDED). FOLLOWING THE USE OF THE PEN, THE PT'S BLOOD SUGAR LEVEL INCREASED AND PT WAS HOSPITALIZED (LAB DATA NOT PROVIDED). DURING THE HOSPITALIZATION, THE OPAQUE CARTRIDGE HOLDER WAS CHANGED TO A CLEAR CARTRIDGE HOLDER UPON THE PT'S COMPLAINT ABOUT THE PEN. ON AN UNKNOWN DATE, THE INCREASED BLOOD SUGAR LEVEL RESOLVED. AFTER THE CARTRIDGE HOLDER CHANGE, THE PT EXPERIENCED DIARRHEA (DATE NOT PROVIDED). A COLON CHECK REVEALED NO ABNORMALITY, AND PT WAS PRESCRIBED AN UNSPECIFIED ANTIDIARRHEAL MEDICATION. AS OF JAN 2004, OUTCOME OF THE DIARRHEA WAS UNKNOWN. IT WAS UNKNOWN IF HUMACART 3/7 WAS CONTINUED. THIS HUMACART 3/7 REPORT IS ASSOCIATED WITH THE HUMAPEN ERGO COMPLAINT REPORT, CID00220281. THE OPERATOR OF THE HUMAPEN ERGO (LOT# UNKNOWN) WAS NOT PROVIDED. IT WAS UNKNOWN IF THE PEN WOULD BE RETURNED TO THE AFFILIATE QC. NO FURTHER INFORMATION IS EXPECTED. CASE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR FMF ELI LILLY AND CO. MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization