BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO BURGUNDY/CLEAR

    MDR report key: 1600280 · Received February 17, 2010

    Report

    Report Number
    1819470-2010-00006
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    November 1, 2009
    Report Date
    January 28, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: A CUSTOMER REPORTED THAT THE DEVICE INJECTION SCREW WAS NOT WORKING. THE ACTUAL COMPLAINT DEVICE WAS RETURNED FOR AN INVESTIGATION. THE DEVICE FROM BATCH 0612A02 WAS MANUFACTURED IN DECEMBER 2006. THE DEVICE WAS TESTED AND MET DOSE ACCURACY GLIDE FORCE SPECIFICATION. NO MALFUNCTION IDENTIFIED. THERE IS EVIDENCE OF IMPROPER USE. THE CUSTOMER REUSES NEEDLES WHICH CAN RESULT IN AN UNDERDOSE.

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION OCCURRED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    (B) (4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY TO OBTAIN DEVICE RELATED INFORMATION, CONCERNS A (B) (6) FEMALE PATIENT OF UNKNOWN ORIGIN. THE MEDICAL HISTORY OF THE PATIENT INCLUDED: DIABETES, NEUROPATHY, BLOOD PRESSURE DISORDER, ANEMIA, URINARY DISORDER, NAUSEA AND SCABIES. CONCOMITANT MEDICATIONS INCLUDED: METFORMIN AND VILDAGLIPTIN, BOTH FOR DIABETES; ACETYLSALICYLIC ACID TO MAKE BLOOD MORE FLUID; FUROSEMIDE FOR BLOOD PRESSURE; SPIRINOLACTONE FOR URINARY DISORDER, PREGABALIN FOR NEUROPATHY; IRON SULFATE FOR ANEMIA; DIMENHYDRINATE + PYRIDOXINE HYDROCHLORIDE FOR NAUSEA AND AN UNSPECIFIED MEDICATION REPORTED AS LICIZINE FOR SCABIES. THE PATIENT RECEIVED INSULIN LISPRO 25% + INSULIN 75% NPL (HUMALOG MIX 25), 46 IU EACH MORNING AND 20 IU EACH EVENING, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES, BEGINNING ON (B) (6)-2008. ON UNSPECIFIED DATES IN (B) (6)-2009, APPROXIMATELY ONE YEAR AND SIX MONTHS AFTER THE BEGINNING OF THE TREATMENT VIA HUMAPEN ERGO TEAL CLEAR WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT 06012A02), THE PATIENT WAS HOSPITALIZED FOR THREE TIMES DUE TO DIABETES AND NEUROPATHY. THE FIRST HOSPITALIZATION LASTED THREE DAYS; THE SECOND AND THIRD EPISODES LASTED ONE WEEK (ACCURATE DATES WERE NOT PROVIDED). THE REPORTER REFERRED THAT THE PATIENT HAS NEVER CARED ABOUT HER DIABETES, SHE WAS A SMOKER AND ALCOHOL DRINKER. THE PATIENT UNDERWENT SEVERAL EXAMS THAT INCLUDED X-RAYS, BLOOD TESTS AND RESONANCE IMAGING BUT THE RESULTS WERE NOT PROVIDED. FOLLOWING HOSPITALIZATIONS, THE INSULIN LISPRO 25% + INSULIN 75% NPL DOSE WAS INCREASED (UNKNOWN DOSE), METFORMIN AND VILDAGLIPTIN WERE ADDED TO THE TREATMENT. ADDITIONALLY, ON (B) (6)-2010, THE PATIENT EXPERIENCED BLOOD GLUCOSE INCREASED WHICH ACCORDING TO THE PATIENT OCCURRED BECAUSE THE INJECTION SCREW OF THE HUMAPEN WAS NOT WORKING PROPERLY. AS A CORRECTIVE TREATMENT, THE PATIENT RECEIVED 46 IU OF INSULIN LISPRO 25% + INSULIN 75% NPL VIA SYRINGE BUT IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE BLOOD GLUCOSE INCREASED. IT WAS NOT REPORTED IF THE INSULIN LISPRO 25% + INSULIN 75% NPL TREATMENT WAS CONTINUED. THIS CASE IS ASSOCIATED TO A PRODUCT COMPLAINT. IT WAS NOT REPORTED WHO OPERATED THE DEVICE AND IF THE OPERATOR WAS TRAINED. IT WAS UNKNOWN HOW LONG THIS DEVICE MODEL AND THE REPORTED DEVICE HAD BEEN USED. IF THE DEVICE IS RETURNED EVALUATION WILL BE PERFORMED TO VERIFY IF A MALFUNCTION OCCURRED. THE HUMAPEN ERGO TEAL CLEAR WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS DISCONTINUED. UPDATE 09-FEB-2010: UPON INTERNAL REVIEW ON 05-FEB-2010: CORRECTED THE IMPROPER USE AND STORAGE FIELD TO YES. UPDATED CORRESPONDING FIELD

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY TO OBTAIN DEVICE RELATED INFORMATION, CONCERNS A (B)(6) FEMALE PATIENT OF UNKNOWN ORIGIN. THE MEDICAL HISTORY OF THE PATIENT INCLUDED: DIABETES, NEUROPATHY, BLOOD PRESSURE DISORDER, ANEMIA, URINARY DISORDER, NAUSEA AND SCABIES. CONCOMITANT MEDICATIONS INCLUDED: METFORMIN AND VILDAGLIPTIN, BOTH FOR DIABETES; ACETYLSALICYLIC ACID TO MAKE BLOOD MORE FLUID; FUROSEMIDE FOR BLOOD PRESSURE; SPIRINOLACTONE FOR URINARY DISORDER, PREGABALIN FOR NEUROPATHY; IRON SULFATE FOR ANEMIA; DIMENHYDRINATE + PYRIDOXINE HYDROCHLORIDE FOR NAUSEA AND AN UNSPECIFIED MEDICATION REPORTED AS LICIZINE FOR SCABIES. THE PATIENT RECEIVED INSULIN LISPRO 25% + INSULIN 75% NPL (HUMALOG MIX 25), 46 IU EACH MORNING AND 20 IU EACH EVENING, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES, BEGINNING ON (B)(6) 2008. ON UNSPECIFIED DATES IN (B)(6) 2009, APPROXIMATELY ONE YEAR AND SIX MONTHS AFTER THE BEGINNING OF THE TREATMENT VIA HUMAPEN ERGO TEAL CLEAR WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT 06012A02), THE PATIENT WAS HOSPITALIZED FOR THREE TIMES DUE TO DIABETES AND NEUROPATHY. THE FIRST HOSPITALIZATION LASTED THREE DAYS; THE SECOND AND THIRD EPISODES LASTED ONE WEEK (ACCURATE DATES WERE NOT PROVIDED). THE REPORTER REFERRED THAT THE PATIENT HAS NEVER CARED ABOUT HER DIABETES, SHE WAS A SMOKER AND ALCOHOL DRINKER. THE PATIENT UNDERWENT SEVERAL EXAMS THAT INCLUDED X-RAYS, BLOOD TESTS AND RESONANCE IMAGING BUT THE RESULTS WERE NOT PROVIDED. FOLLOWING HOSPITALIZATIONS, THE INSULIN LISPRO 25% + INSULIN 75% NPL DOSE WAS INCREASED (UNKNOWN DOSE), METFORMIN AND VILDAGLIPTIN WERE ADDED TO THE TREATMENT. ADDITIONALLY, ON (B)(6) 2010, THE PATIENT EXPERIENCED BLOOD GLUCOSE INCREASED WHICH ACCORDING TO THE PATIENT OCCURRED BECAUSE THE INJECTION SCREW OF THE HUMAPEN WAS NOT WORKING PROPERLY. IT WAS REPORTED THAT THE PATIENT REUSED THE NEEDLES. AS A CORRECTIVE TREATMENT THE PATIENT RECEIVED 46 IU OF INSULIN LISPRO 25% + INSULIN 75% NPL VIA SYRINGE BUT IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE BLOOD GLUCOSE INCREASED. IT WAS NOT REPORTED IF THE INSULIN LISPRO 25% + INSULIN 75% NPL TREATMENT WAS CONTINUED. THIS CASE IS ASSOCIATED TO A PRODUCT COMPLAINT. IT WAS NOT REPORTED WHO OPERATED THE DEVICE AND IF THE OPERATOR WAS TRAINED. IT WAS UNKNOWN HOW LONG THIS DEVICE MODEL AND THE REPORTED DEVICE HAD BEEN USED. IF THE DEVICE IS RETURNED EVALUATION WILL BE PERFORMED TO VERIFY IF A MALFUNCTION OCCURRED. THE HUMAPEN ERGO TEAL CLEAR WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS DISCONTINUED. UPDATE (B)(6) 2010: UPON INTERNAL REVIEW ON (B)(6) 2010: CORRECTED THE IMPROPER USE AND STORAGE FIELD TO YES. UPDATED CORRESPONDING FIELD. UPDATE (B)(6) 2010: PER INTERNAL REVIEW ON (B)(6) 2010, UPDATED THE LOT NUMBER FROM 06012A02 TO 0612A02 AND CLARIFIED IN NARRATIVE THE MISUSE DESCRIPTION THAT WAS ALREADY MARKED IN THE CASE. UPDATE (B)(6) 2010. ADDITIONAL INFORMATION RECEIVED FROM THE GLOBAL PRODUCT COMPLAINT SYSTEM ON (B)(6) 2010: ADDED THE RETURNED TO MANUFACTURER ON DATE AS (B)(6) 2010; CHANGED THE MALFUNCTION FILED FROM UNKNOWN TO NO; INCLUDED DEVICE SAFETY SUMMARY. UPDATED CORRESPONDENT FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS8930 0612A02

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization