BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR/CLEAR CH

    MDR report key: 932092 · Received October 22, 2007

    Report

    Report Number
    1819470-2007-00044
    Event Type
    Injury
    Date Received
    October 22, 2007
    Report Date
    August 5, 2007
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVAL WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED.

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY A PHYSICIAN VIA SALES REP, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A FEMALE PT OF UNK ORIGIN. THE PT MEDICAL HISTORY INCLUDED DIABETES. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE, INSULIN HUMAN AND AN UNK MEDICATION, WITH INDICATIONS FOR USE NOT PROVIDED. THE PT WAS TAKING INSULIN LISPRO 25% + INSULIN NPL 75% (HUMALOG MIX), 46U, UNK FREQUENCY, SUBCUTANEOUSLY FOR DIABETES TREATMENT, BEGINNING ON AN UNSPECIFIED DATE. IN 2007, AN UNSPECIFIED TIME PERIOD AFTER STARTING INSULIN LISPRO 25% + INSULIN NPL 75%, VIA THE HUMAPEN ERGO TEAL/CLEAR PEN BODY (UNK LOT) WITH A CARTRIDGE HOLDER ATTACHED (UNK LOT), THE PHYSICIAN REPORTED THAT DUE TO HUMAPEN FAULT, THE PT DID NOT REACH IN SEVERAL DAYS A SUITABLE GLYCEMIC CONTROL (HE DID NOT SPECIFY THE START DATE). IT WAS UNK IF THE PT RECEIVED CORRECTIVE TREATMENT FOR THIS EVENT AND IF SHE RECOVERED OR NOT. THE REPORTER STATED THAT THE PT REFERRED TO HAVE DOUBTS ABOUT THE USE AND OPERATION OF HE HUMAPEN, ONCE THE CARTRIDGE PLACED INSIDE OF THE PEN, WHICH CONTAINED CERTAIN AMOUNT OF INSULIN, IN HIS OPINION SHOULD BE USED BY THE PT. ACCORDING TO THE REPORTER, THE PT EXPERIENCED HYPERGLYCEMIA DUE TO INAPPROPRIATE USE OF THE HUMAPEN AND ON THE SAME DAY, SHE WAS HOSPITALIZED FOR A BETTER CONTROL OF GLYCEMIA; HE ALSO STATED THAT THE HYPERGLYCEMIA DID NOT THREAT THE PT LIFE. IT WAS UNK IF THE PT UNDERWENT LABORATORY EXAMS. THE PT RECEIVED INSULIN REGULAR AND INSULIN ISOPHANE INJECTION AS CORRECTIVE TREATMENTS FOR HYPERGLYCEMIA, BUT IT WAS UNK IF SHE RECOVERED OR NOT. THE PT WAS DISCHARGED ON THE NEXT DAY. IT WAS NOT INFORMED IF THE INSULIN LISPRO 25% + INSULIN NPL 75% TREATMENT WAS CONTINUED. THIS HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH ANOTHER DEVICE. IT WAS UNK IF THE PT OPERATED THE DEVICE AND IF THE OPERATOR WAS TRAINED. IT WAS NOT REPORTED THE TIME PERIOD THE PT HAD USED THIS DEVICE MODEL, AND THE REPORTED DEVICE. THE DEVICE WAS NOT RETURNED TO THE MFR YET. IT WAS UNK IF THE HUMAPEN ERGO TEAL/CLEAR WAS SWITCHED TO A NEW DEVICE. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY RELATIONSHIP AMONG NOT REACHING THE GLYCEMIC CONTROL, THE SUSPECTED DRUG AND THE DEVICE, BUT HE STATED THAT THE HYPERGLYCEMIA HAPPENED, DUE TO AN UNAPPROPRIATED USE OF THE HUMAPEN, AND THAT IT WAS NOT RELATED TO THE INSULIN LISPRO 25% + INSULIN NPL 75% USE. UPDATED ON THE FOLLOWING MONTH. ADD'L INFO RECEIVED ON TWO DAYS EARLIER FROM THE INITIAL REPORTER. ADDED SUSPECTED DRUG INDICATION FOR USE. ADDED A NEW EVENT (HYPERGLYCEMIA) AND THE HOSPITALIZATION SERIOUSNESS CRITERIA. ADDED CAUSALITY OPINION. ADDED CONCOMITANT MEDICATIONS AND CORRECTIVE TREATMENT. UPDATED NARRATIVE, PSUR COMMENTS AND RELATED FIELDS. UPDATED ON THE FOLLOWING MONTH. ADD'L INFO RECEIVED ONE DAY EARLIER. ADDED THE HUMALOG MIX AND THE HUMAPEN COUNTRY (GUATEMALA). UPDATED ON TWO DAYS LATER, ADDITIONAL INFORMATION RECEIVED ON THE DAY BEFORE. ADDED THE DEVICE LOT NUMBER WAS UNK. UPDATED NARRATIVE AND CORRESPONDENT FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR/CLEAR CH PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8929 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization