BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 385545 · Received March 28, 2002

    Report

    Report Number
    1819470-2002-00012
    Event Type
    Injury
    Date Received
    March 28, 2002
    Date of Event
    January 1, 2002
    Report Date
    February 28, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES A SERIOUS ADVERSE EVENT, REPORTED BY A PHARMACIST CONCERNS A PT. THE PT WAS RECEIVING HUMAN INSULIN UNKNOWN FORMULATION IN A PEN INJECTION DEVICE (HUMAPEN ERGO - NOT MORE SPECIFIED) FOR TREATMENT OF TYPE II DIABETES MELLITUS. IT IS UNKNOWN, IF THE PT WAS A TRAINED USER AND HOW LONG THE DEVICE WAS USED. NEITHER MEDICAL SIGNIFICANT HISTORY NOR CONCOMITANT DRUGS WERE PROVIDED. THE PT SUFFERED FROM INCREASED BLOOD GLUCOSE (>600 MG/DL, PHARMACIST STATED THE EVENT WAS LIFE THREATENING) AND GOT HOSPTIALIZED CONSCIOUS - DATES UNKNOWN. THE PT HAS FULLY RECOVERED BUT IT IS UNKNOWN IF HUMAN INSULIN UNKNOWN FORMULATION IS CONTINUING. THE PT COMPLAINED A MALFUNCTION OF THE PEN - NOT MORE SPECIFIED. THE PHARMACIST HAS SENT THE HUMAPEN ERGO TO THE CO FOR ANALYSIS BUT QUALITY CONTROL RECEIVED AN EMPTY AND TORN PARCEL. THE DEVICE WAS LOST ON THE WAY OF DELIVERY. NO DEVICE IS AVAILABLE FOR EVAL. THE PHARMACIST TRIES TO GET MORE INFO CONCERNING THE EVENT. THIS COMPLAINT IS CROSS-REFERENCED TO CID128787. HUMAPEN ERGO - NOT MORE SPECIFIED (LOST ON THE WAY OF DELIVERY). 3/2002: PHARMACEUTICAL DELIVERY SYSTEMS UNABLE TO PROVIDE DETAILED ANALYSIS AS MATERIAL WAS NOT RECEIVED TO EXAMINE. PDS IS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE USER'S DIFFICULTY. UPDATED 3/2002: PHARMACEUTICAL DELIVERY SYSTEMS ENTERED RESULTS/CONCLUSIONS AND CORRECTIVE ACTION ON THE SUSPECT DEVICE PAGE, UPDATED THE NARRATIVE AND THE CIOMS-II FIELD. UPDATE 3/2002: AFTER CO REVIEW, CORRECT PT AND CLINICAL EVENT OUTCOME, CORRECT CIOMS FIELD. UPDATE 3/2002: PHARMACEUTICAL DELIVERY SYSTEMS: CORRECTED TYPING/WORDING ERROR IN RESULTS / CONCLUSION AND NARRATIVE. UPDATE 3/2002: AFTER CO REVIEW, CHANGE MALFUNCTION FROM YES TO UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization