BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN-ERGO, TEAL/CLEAR

    MDR report key: 5324436 · Received September 17, 2004

    Report

    Report Number
    1819470-2004-00021
    Event Type
    Other
    Date Received
    September 17, 2004
    Report Date
    August 20, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    NSC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S PRELIMINARY COMMENTS: INVESTIGATION IN PROGRESS. ADD'L MANUFACTURER NARRATIVE: NO FURTHER F/U IS PLANNED. OTHER OUTCOME. MED SIGNIFICANT. PEN BODY (LOT 40235), WITH A CLEAR CARTRIDGE HOLDER ATTACHED, FOR THE TREATMENT OF DIABETES (NO START DATE PROVIDED). ON AN UNSPECIFIED DATE, WHILST RECEIVING INSULIN LISPRO VIA A HUMAPEN, THE PATIENT EXPERIENCED HYPOS AND WAS PASSING OUT. THE REPORTER STATED THAT THE PATIENT BELIEVED HIS HUMAPEN WAS NOT DELIVERING THE DOSE PROPERLY AS THE CARTRIDGE HOLDER WAS FALLING INTO TWO AND OUT OF THE PEN AND THAT IT WAS DIFFICULT TO INJECT WITH. THE PERSON OPERATING THE DEVICE WAS THE PATIENT WHO WAS A TRAINED USER. THE PATIENT USED 8MM BECTON DICKINSON NEEDLES AND REUSED EACH NEEDLE UNTIL IT HURT. THE PATIENT NEVER PRIMED THE PEN, INJECTED INTO HIS ABDOMEN. THE DEVICE WAS TWO YEARS OLD. AT THE TIME OF REPORTING IT IS UNKNOWN IF THE PATIENT HAS RECOVERED OR WHETHER THERAPY WITH INSULIN LISPRO CONTINUES. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH (B)(4). FURTHER INFORMATION WAS REQUESTED BUT THE INITIAL REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THESE EVENTS ARE UNASSESSED BY A HEALTHCARE PROFESSIONAL. THE DEVICE WAS RETURNED TO THE COMPANY FOR EVALUATION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ADDITIONAL EVALUATION AND CONCLUSION. THE ACTUAL COMPLAINT DEVICE WAS RETURNED, HOWEVER, IT WAS RECEIVED IN A CONDITION THAT WAS NOT POSSIBLE TO TEST. THE IDENTIFIED MALFUNCTIONS WERE FOOT DETACHED, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE, AND INJECTION BUTTON DETACHED, WHICH RENDERS THE DEVICE UNUSABLE. CORRECTIVE ACTION: A REDESIGNED FOOTPAD, WHICH REQUIRES HIGHER FORCE TO DETACH, WAS IMPLEMENTED IN (B)(4) 2002 BEGINNING WITH LOT 40277. ADDITIONALLY, A NEW DESIGN THAT CAN WITHSTAND HIGHER FORCES WAS IMPLEMENTED IN (B)(4) 2003 BEGINNING WITH LOT 150203. EVIDENCE OF IMPROPER USE: THE USER PROVIDED INFORMATION TO INDICATE THAT THE PRODUCT WAS USED IMPROPERLY. USER INDICATED NEEDLE REUSE, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE, AND USER DID NOT PRIME THE DEVICE, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE. UPDATE 07-SEP-2004: FINAL GPCMS REPORT RECEIVED ON 03-SEP-2004. MALFUNCTION IDENTIFIED. AERS SUMMARY ADDED. DEVICE PAGE AND NARRATIVE UPDATED ACCORDINGLY. UPDATE 10-SEP-2004: ADDITIONAL INFORMATION RECEIVED FROM INITIAL REPORTER ON THE 10-SEP-2004, UPDATED MEDICAL HISTORY SECTION AND ADDED THAT NO FURTHER INFORMATION IS AVAILABLE. CASE CLOSED. DIABETES, FIBROSIS OF THE LUNGS AND UNSPECIFIED BLOOD PRESSURE PROBLEMS, GOING BLIND AND PREVIOUS IRRADIATION. RESULTS/CONCLUSIONS: THIS DEVICE IS USED FOR TREATMENT PURPOSES. THE ACTUAL COMPLAINT DEVICE WAS RETURNED, HOWEVER, IT WAS RECEIVED IN A CONDITION THAT WAS NOT POSSIBLE TO TEST. THE IDENTIFIED MALFUNCTIONS WERE FOOT DETACHED, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE, AND INJECTION BUTTON DETACHED, WHICH RENDERS THE DEVICE UNUSABLE. CORRECTIVE ACTION: A REDESIGNED FOOTPAD, WHICH REQUIRES HIGHER FORCE TO DETACH, WAS IMPLEMENTED IN (B)(4) 2002 BEGINNING WITH LOT 40277. ADDITIONALLY, A NEW DESIGN THAT CAN WITHSTAND HIGHER FORCES WAS IMPLEMENTED IN (B)(4) 2003 BEGINNING WITH LOT 150203. EVIDENCE OF IMPROPER USE: THE USER PROVIDED INFORMATION TO INDICATE THAT THE PRODUCT WAS USED IMPROPERLY. USER INDICATED NEEDLE REUSE, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE, AND USER DID NOT PRIME THE DEVICE, WHICH HAS BEEN SHOWN TO RESULT IN A POSSIBLE UNDERDOSE.

    Description of Event or Problem · 1

    THIS CASE REPORTED BY A NON-HEALTHCARE PROFESSIONAL WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A (B)(6) MALE PT. THE PT'S MEDICAL HISTORY INCLUDED DIABETES, FIBROSIS OF THE LUNGS AND UNSPECIFIED BLOOD PRESSURE PROBLEMS, GOING BLIND, AND PREVIOUS IRRADIATION. CONCOMITANT MEDICATION INCLUDED ISOPHANE INSULIN (INSULATARD), OXYGEN, PERINDOPRIL (REPORTED AS PIRINDOPRIL), AND UNSPECIFIED STATINS. THE PT RECEIVED INSULIN LISPRO (HUMALOG), 26 UNITS IN THE MORNING, 14 UNITS IN THE AFTERNOON AND 20 UNITS AT NIGHT, DELIVERED VIA A HUMAPEN ERGO TEAL / CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN-ERGO, TEAL/CLEAR PEN INJECTOR NSC ELI LILLY AND CO. MS8929 40235

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other