BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 359845 · Received November 1, 2001

    Report

    Report Number
    1819470-2001-00056
    Event Type
    Injury
    Date Received
    November 1, 2001
    Date of Event
    January 1, 2001
    Report Date
    October 10, 2001
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORTED BY A PHYSICIAN CONCERNS A PT, WHO USED THE HUMAPEN ERGO FOR TREATMENT OF DIABETES MELLITUS TYPE II. THE PT WAS TAKING 25% INSULIN LISPRO/75% INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG MIX 25). NO CONCOMITANT DRUGS WERE PROVIDED. THE PT USED THE HUMAPEN ERGO AND HUMALOG MIX 25 CARTRIDGES SINCE AN UNKNOWN TIME. THE PT TRIED TO INJECT INSULIN BUT THE NEEDLE HAS BEEN BROKEN AND GOT STUCK IN THE BELLY. THIS EVENT HAPPENED TWICE - TIME UNKNOWN. IT IS UNKNOWN IF THE NEEDLES WERE CHANGED AFTER INJECTION ALL THE TIME. THE PHYSICIAN SENT THE PT TO A SURGEON FOR REMOVAL OF THE NEEDLE PIECES BUT WITHOUT ANY SUCCESS. IT IS UNKNOWN IF HUMALOG MIX IS CONTINUING. THE PEN HAS BEEN SENT TO QUALITY CONTROL FOR EVAL. THE PHYSICIAN DID NOT CONSIDER THE EVENT TO BE CAUSALLY RELATED TO HUMALOG MIX 25. UPDATE 09/2001: AFTER CO REVIEW, CHANGE PT EVENT-SERIOUS CRITERIA "REQUIRED INTERVENTION" TO YES. UPDATE 09/2001: AFTER REVIEW, CHANGE MALFUNCTION FROM YES TO NO. F/U 10/2001: INITIAL INVESTIGATION BY QC GIESSEN IN 10/2001, CHANGE DEVICE, UPDATE EVENT SUMMARY. F/U 10/2001: ADDITIONAL INFORMATION REC'D IN 10/2001, CHANGE PT AND CLINICAL EVENT OUTCOME, UPDATE EVENT SUMMARY.

    Description of Event or Problem · 1

    THE NEEDLES (MICROFINE 8 MM, DIAMETER 0.25 MM) WERE USED THE FIRST TIME AND THE NEEDLES WERE NOT BENT BEFORE USAGE. HUMALOG MIX IS CONTINUING.

    Description of Event or Problem · 1

    THE NEEDLES (MICROFINE 8 MM, DIAMETER 0.25 MM) WERE USED THE FIRST TIME AND THE NEEDLES WERE NOT BENT BEFORE USAGE. HUMALOG MIX IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48965 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR KZE ELI LILLY AND COMPANY MS8929 A1495

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention