BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 384240 · Received March 21, 2002

    Report

    Report Number
    1819470-2002-00008
    Event Type
    Injury
    Date Received
    March 21, 2002
    Date of Event
    February 23, 2002
    Report Date
    February 25, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY A CONSUMER, CONCERNS A MALE PATIENT WHO EXPERIENCEDABNORMAL BLOOD SUGAR LEVES. THE PATEINT REPORTED THAT THEY WERE TAKING HUMAN INSULIN RECOMBINANT DNA (HUMULIN NPH) VIA A HUMAPEN ERGO TEAL DEVICE FOR TREATMENT OF DIABETES. THE DEVICE WAS OPERATED BY THE CONSUMER. IT IS UNKNOWN IF THE CONSUMER WAS A TRAINED THEY HAD USED THE DEVICE FOR APPROX TWO YEARS. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS ARE UNKNOWN. IN 2002, APPROX TWO YEARS AFTER BEGINNING HUMAN INSULIN RDNA VIA THE HUMAPEN ERGO (LOT NUMBER A1377/MODEL NUMBER MS8335), THE PATIENT EXPERIENCED BLOOD SUGAR LEVELS BETWEEN 2.5 TO GREATER THAN 13.6. THE PATIENT BECAME UNWELL AN DPRESENTED TO HIS LOCAL HOSPITAL WHERE INSULIN WAS ADMINISTERED. HE STABILISED AND WAS SENT HOME WITHOUT ADMISSION. THE PATIENT STATED THAT HIS HUMAPEN ERGO WAS NOT DELIVERING INSULIN AND THAT THE PLUNGER WAS HARD TO DEPRESS. THE DEVICE WAS RETURNED TO THE CO FOR ANALYSIS. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPT FOUND: A CLEAR CARTRIDGE HOLDER ATTACHED TO A HUMAPEN ERGO TEAL/OPAQUE BODY (MS8335, LOT NUMBER A1377). NO FAULT COULD BE FOUND ON VISUAL EXAMINATION. THE HUMAN INSULIN RDNA TREATMENT WAS CONTINUED. THE PATIENT WAS SHOWN HOW TO INJECT HIMSELF WHILST HE WAITED FOR A REPLACMENT DEVICE. ONCE HE RECEIVED THE DEVICE HE RETURNED TO ADMINISTERING HIS INSULIN VIA THE NEW DEVICE. THE PATIENT HAS FULLY RECOVERED. THIS CASE IS UN ASSESSED FOR CAUSALITY AS THE REPORTER WAS NOT A HEALTH CARE PROFESSIONAL.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY A CONSUMER, CONCERNS A PATIENT WHO EXPERIENCED ABNORMAL BLOOD SUGAR LEVELS. THE PATIENT REPORTED THAT THEY WERE TAKING HUMAN INSULIN RECOMBINANT DNA (HUMULIN NPH) VIA A HUMAPEN ERGO TEAL DEVICE FOR TREATMENT OF DIABETES. THE DEVICE WAS OPERATED BY THE CONSUMER. IT IS UNKNOWN IF THE CONSUMER WAS A TRAINED, THEY HAD USED THE DEVICE FOR APPROXIMATELY TWO YEARS. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS ARE UNKNOWN. IN 2002, APPROXIMATELY TWO YEARS AFTER BEGINNING HUMAN INSULIN RDNA VIA THE HUMAPEN ERGO (LOT NUMBER A1377/MODEL NUMBER MS8335), THE PATIENT EXPERIENCED BLOOD SUGAR LEVELS BETWEEN 2.5 TO GREATER THAN 13.6. THE PATIENT BECAME UNWELL AND PRESENTED TO THEIR LOCAL HOSPITAL WHERE INSULIN WAS ADMINISTERED. PATIENT HUMAPEN ERGO WAS NOT DELIVERING INSULIN AND THAT THE PLUNGER WAS HARD TO DEPRESS. THE DEVICE WAS RETURNED TO THE COMPANY FOR ANALYSIS. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPARTMENT FOUND: A CLEAR CARTRIDGE HOLDER ATTACHED TO A HUMAPEN ERGO TEAL/OPAQUE BODY (MS8335, LOT NUMBER A1377). NO FAULT COULD BE FOUND ON VISUAL EXAMINATION. THE HUMAN INSULIN RDNA TREATMENT WAS CONTINUED. THE PATIENT WAS SHOWN HOW TO INJECT THEMSELVES WHILE THE PT WAITED FOR A REPLACEMENT DEVICE. ONCE PT REC'D THE DEVICE THEY RETURNED TO ADMINISTERING THEIR INSULIN VIA THE NEW DEVICE. THE PATIENT HAS FULLY RECOVERED. THIS CASE IS UNASSESSED FOR CAUSALITY AS THE REPORTER WAS NOT A HEALTH CARE PROFESSIONAL. UPDATED MAR 2002: CHANGED EVENT TO ABNORMAL BLOOD SUGARS, UPDATED EVENT PAGE, DEVICE PAGES AND NARRATIVE AS PER REVIEW.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY A CONSUMER, CONERNS A PATIENT WHO EXPERIENCEDABNORMAL BLOOD SUGAR LEVELS. THE PATIENT REPORTED THAT THEY WERE TAKING HUMAN INSULIN RECOMBINANT DNA (JHUMULIN NPH) VIA A HUMAPEN ERGO TEAL DEVICE FOR TREATMENT OF DIABETES. THE DEVICE WAS OPERATED BY THE CONSUMER. IT IS UNKNOWN IF THE CONSUMER WAS A TRAINED THEY HAD USED THE DEVICE FOR APPROX TWO YEARS. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS ARE UNKNOWN. IN 2002, APPROX TWO YEARS AFTER BEGINNING HUMAN INSULIN RNDA VIA THE HUMAPEN ERGO (LOT NUMBER A1377/MODEL NUMBER MS8335), THE PATIENT EXPERIENCED BLOOD SUGAR LEVELS BETWEEN 2.5 TO GREATER THAN 13.6. THE PATIENT BECAME UNWELL AND PRESENTED TO THEIR LOCAL HOSPITAL WERE INSULIN WAS ADMINSITERED. PATIENT STABLISED AND WAS SENT HOME WITHOUT ADMISSION. THE PATIENT STATED THAT THEIR HUMAPEN ERGO WAS NOT DELIVERING INSULIN AND THAT THE PLUNGER WAS HARD TO DEPRESS. THE DEVICE WAS RETURNED TO THE CO FOR ANALYSIS. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPARTMENT FOUND: A CLEAR CARTRIDGE HOLDER ATTACHED TO A HUMAPEN ERGO TEAL/OPAQUE BODY (MS8335, LOT NUMBER A1377). NO FAULT COULD BE FOUND ON VISUAL EXAMINATION. THE HUMAN INSULIN RDNA TREATMENT WAS CONTINUED. THE PATIENT WAS SHOWN HOW TO INJECT THEIRSELF WHILST THEY WAITED FOR A REPLACMENT DEVICE. ONCE PATIENT RECEIVED THE DEVICE PATIENT RETURNED TO ADMINISTERING THE INSULIN VIA THE NEW DEVICE. THE PATIENT HAS FULLY RECOVERED. THIS CASE IS UN ASSESSED FOR CAUSALITY AS THE REPORTER WAS NOT A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1377

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other