BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, BURGUNDY/CLEAR

    MDR report key: 997382 · Received February 7, 2008

    Report

    Report Number
    1819470-2008-00004
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 1, 2007
    Report Date
    November 23, 2007
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVAL WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. THIS REPORT IS ASSOCIATED WITH 1819470-2008-00005, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED. NOTE: THIS REPORT INCLUDES FINAL EVAL FINDINGS. NO ADD'L INFO IS EXPECTED. EVAL SUMMARY: FIVE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE COMPLAINT DEVICE (LOT 0406A04, MFG JUNE 2004). THUS, THE USER'S COMPLAINT, DEVICE NOT WORKING COULD NOT BE CONFIRMED. MALFUNCTION UNK. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    THIS INITIAL CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE CO TO REPORT A PROD COMPLAINT WITH ADD'L INFO REPORTED BY THE SAME CONSUMER RPTR, CONCERNS MALE OF UNSPECIFIED AGE AND ORIGIN. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT FIRST REC'D HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N) AND HUMAN REGULAR INSULIN (HUMULIN R) (LOT #S WERE NOT OBTAINED) VIA TWO SEPARATE HUMAPEN ERGO BURGUNDY/CLEAR PENS, FOR TREATMENT OF DIABETES. HE BEGAN USING HUMULIN N AND HUMULIN R ALONG WITH HUMAPEN ERGO DEVICES TEN YRS AGO (1997). HE BEGAN USING THESE PARTICULAR HUMAPEN DEVICES IN 2007. HE STATED, THAT THE BUTTON WAS SKIPPING AND THAT HE WAS NOT SURE HE WAS GETTING HIS INSULIN. ON AN UNREPORTED DATE, AFTER BEGINNING USE OF THE HUMAPEN ERGO DEVICES, HIS SUGARS WERE RUNNING A LITTLE LOW (NO VALUES WERE PROVIDED.) THE STATUS OF THE EVENT WAS UNK. THE HUMULIN N AND HUMULIN R WERE CONTINUED. IN AN ADD'L REPORT REC'D 23 NOV 2007, IT WAS REPORTED THAT THE PT NOTICED THAT THE PEN WAS SKIPPING AND ATTEMPTED TO GIVE MORE THAN ONE DOSE AND TESTED HIS BLOOD SUGAR LEVELS AT THAT TIME. HE CONSUMED EXTRA SUGAR/FOOD AND REQUIRED HELP FROM HIS SPOUSE AND EMERGENCY PERSONNEL. NEITHER GLUCAGON OR IV MEDICATIONS WERE REQUIRED. THIS HUMULIN N AND HUMULIN R CASE CONTAINED A PROD COMPLAINT SUSPECT DEVICE CID00543411 (LOT # 406A04) AND A PROD COMPLAINT SUSPECT DEVICE CID00543412 (LOT # 0608A02). THE PT WAS THE OPERATOR OF BOTH HUMAPEN ERGO BURGUNDY/CLEAR PENS. HE WAS TRAINED USER OF THE GENERAL DEVICE AND PROBLEM DEVICES FOR APPROX ONE MONTH. THE HUMAPEN DEVICES WERE BOTH STORED AT ROOM TEMP AND PRIMED BEFORE EVERY INJECTION. THE RETURN OF BOTH DEVICES WAS NOT ANTICIPATED. IN A F/U REPORT FROM 23NOV2007, THE RPTR PROVIDED THE LOT # OF HUMULIN N CARTRIDGE AS A181899. UPDATE 15OCT07: ADD'L INFO WAS REC'D FROM THE PHARMACIST 04OCT07 STATING THAT THE DEVICES WILL NOT BE RETURNED AS HE HAD MISPLACED THE ENVELOPE. UPDATE 03DEC2007: ADD'L INFO WAS REC'D FROM THE INITIAL RPTR ON 23NOV2007: ADDED LENGTH OF TREATMENT WITH INSULINS AND TYPE OF PENS, ADDED LOT # OF HUMULIN N, PRIMING BEFORE EACH USE, EATING EXTRA FOOD/SUGAR, AND REQUIRED HELP FROM SPOUSE AND EMERGENCY PERSONNEL. UPDATE 06-FEB-2008: UPON INTERNAL REVIEW OF INFO REC'D 23-NOV-2007, ADDED F/U DATE OF 23-NOV -2007 MARKED SIGNIFICANT FOR DEVICE. CORRECTED MOST SIGNIFICANT DEVICE ADVERSE EVENT CATEGORY FIELD FOR BOTH HUMAPEN ERGO PRODS. UPDATE 06-FEB-08: ADD'L INFO DATED 06-FEB-2008 RETRIEVED FROM LILLY GLOBAL PROD COMPLAINT DATABASE. ADDED LSS ANALYSIS SUMMARIES FOR BOTH HUMAPEN ERGO PRODS. AMENDED LOT #S AND EU/CA DEVICE FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8930 0406A04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention