BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO TEAL - CLEAR

    MDR report key: 444538 · Received February 25, 2003

    Report

    Report Number
    1819470-2003-00002
    Event Type
    Other
    Date Received
    February 25, 2003
    Date of Event
    January 28, 2003
    Report Date
    January 30, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NURSE, WHO CONTACTED THE COMPANY TO FIND OUT HOW TO OBTAIN A REPLACEMENT HUMAPEN, CONCERNS A PT. THE PT'S MEDICAL HISTORY INCLUDED HAVING DIABETES FOR A 'GOOD FEW YEARS'. CONCOMITANT MEDICATION INCLUDED TAMOXIFEN, DIPYRIDAMOLE (PERSANTINE), ASPIRIN, FLUTAMIDE AND SALBUTAMOL INHALER (VENTOLIN). THE PT REC'D 30% SOLUBLE INSULIN, 70% ISOPHANE INSULIN (HUMULIN M3), 12 UNITS IN THE MORNING AND 10 UNITS AT TEA TIME, VIA A PEN INJECTION DEVICE (HUMULIN ERGO) FOR THE TREATMENT OF DIABETES (NO START DATE PROVIDED). IN 2003, THE PT'S BLOOD SUGARS STARTED TO RISE. ON THE EVENING ON THE FOLLOWING DAY, THE PT'S BLOOD SUGARS ROSE TO 33 AND THE PT WAS HOSPITALIZED. THE PT'S NORMAL BLOOD SUGARS ARE AROUND 15. THE REPORTER WAS UNSURE IF THERE WAS ANYTHING WRONG WITH THE PEN. INITIAL EXAM OF THE RETURNED DEVICE REVEALED THAT THE GENERAL CONDITION OF THE PEN WAS GOOD AND THAT THE FOOTPAD WAS DETACHED. AT THE TIME OF REPORTING THE PT HAD NOT RECOVERED. THERAPY WITH 30% SOLUBLE INSULIN, 70% ISOPHANE INSULIN CONTINUES. THE REPORTER WAS UNSURE IF THE EVENT OF HIGH BLOOD SUGARS WAS DUE TO THE HUMAPEN. THIS CASE IS CROSS REFERENCED TO CID166267. UPDATE 2/5/2003: PHARMACEUTICAL DELIVERY SYSTEMS ENTERED INITIAL COMMENTS ON THE SUSPECT DEVICE PAGE. UPDATE 2/10/2003: INITIAL GPCMS REPORT REC'D FROM QA ON THE 2/7/2003. INITIAL COMMENTS ADDED AND CASE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO TEAL - CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8929 A1520

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization