BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA HALF-DOSE PEN

    MDR report key: 3170163 · Received June 14, 2013

    Report

    Report Number
    1819470-2013-00014
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K063151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY A PATIENT'S SON REPORTED THAT HIS MOTHER'S HUMAPEN LUXURA HD DEVICE WAS DELIVERING TOO MUCH INSULIN. THE PATIENT EXPERIENCED HYPOGLYCEMIA. ON A LATER DATE, THE PATIENT REPORTED THAT THE DEVICE WAS NOT DELIVERING INSULIN AND THE INJECTION SCREW WAS NOT MOVING. INVESTIGATION OF THE RETURNED DEVICE (BATCH 1012G01, MANUFACTURED DECEMBER 2010) FOUND THAT THE DEVICE MET FUNCTIONAL REQUIREMENTS AND MET DOSE ACCURACY AND GLIDE (INJECTION) FORCE SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED. THERE IS EVIDENCE OF IMPROPER USE. THE USER REUSES NEEDLES AND DID NOT PRIME THE DEVICE. THIS MAY NOT BE RELEVANT TO THE COMPLAINT OF HYPOGLYCEMIA; HOWEVER, IT MAY BE RELEVANT TO THE REPORT THAT THE DEVICE WAS NOT DELIVERING INSULIN.

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS 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 DEVICE CASE, REPORTED BY CONSUMER WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT, CONCERNS A (B)(6). MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN RDNA ORIGIN (HUMULIN 70N/30R; LOT NUMBER C014790J) CARTRIDGES, UNKNOWN DOSES AND FREQUENCY, SUBCUTANEOUSLY, FOR TREATMENT OF TYPE II DIABETES, BEGINNING IN 1998. ON AN UNKNOWN DATE, SHE STARTED TO RECEIVE HUMAN INSULIN VIA HUMAPEN LUXURA HALF DOSE (HD). ON (B)(6) 2013, APPROXIMATELY 15 YEAR AFTER THE BEGINNING OF THE TREATMENT HUMAN INSULIN RDNA ORIGIN, THE PATIENT EXPERIENCED HYPOGLYCEMIC COMA DUE TO THE HUMAPEN LUXURA HD WAS INJECTING THE DRUG IN AN UNCONTROLLED WAY ((B)(4)). CONFLICTING INFORMATION WAS REPORTED BECAUSE PATIENT HAD THREE OR FOUR DEVICES (UNSPECIFIED IF THEY WERE ALL LILLY DEVICES) AND REPORTER WAS UNSURE WHAT DEVICE WAS USED AT THE TIME OF THE EVENT. HOWEVER, UPON FOLLOW UP, ACCORDING TO THE REPORTER, THE DEVICE THAT WAS RETURNED (LOT NUMBER 1012G01) WAS THE CLAIMED DEVICE. THE EVENT HYPOGLYCEMIC COMA WAS CONSIDERED SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. ON (B)(6) 2013 THE PATIENT RECOVERED FROM HYPOGLYCEMIC COMA. INFORMATION ABOUT CORRECTIVE TREATMENT WAS UNKNOWN. THE DOSE OF HUMAN INSULIN WAS REDUCED TO AVOID HYPOGLYCEMIA. ON (B)(6) 2013 THE PATIENT WAS APPLYING THE MEDICATION IN HERSELF, WITH THE SAME HUMAPEN LUXURA HD, AND REALIZED THAT THE MEDICATION WAS NOT RELEASED. THE PATIENT CHANGED TO ANOTHER DEVICE TO PERFORM THE APPLICATION AND COULD RECEIVE HUMAN INSULIN NORMALLY. THE TREATMENT WITH INSULIN RDNA ORIGIN WAS CONTINUED. THE PATIENT OPERATED THE DEVICE. IT WAS UNKNOWN IF THE PATIENT WAS TRAINED. THEY HAD USED THIS DEVICE MODEL AND THE REPORTED FOR UNSPECIFIED TIME. THE DEVICE WAS RETURNED ON (B)(4) 2013. THE CONSUMER DID NOT PROVIDE AN OPINION OF RELATEDNESS BETWEEN THE EVENTS AND INSULIN RDNA ORIGIN BUT STATED THE EVENT OF HYPOGLYCEMIC COMA WAS RELATED TO THE DEVICE. EDIT (B)(4) 2013: UPON INTERNAL REVIEW, UPDATED NARRATIVE WITH PATIENT GENDER. UPDATE (B)(4) 2013. ADDITIONAL INFORMATION RECEIVED (B)(4) 2013 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. ADDED LOT NUMBER 0803B03 FOR PRODUCT (B)(4); ON DEVICE PRODUCT PAGE CODED THE DEVICE TO HUMAPEN LUXURA, CHAMPAGNE (FROM BODY TYPE UNKNOWN) MODEL NUMBER MS9663, CHANGED IMPROPER USE TO YES, NOTED DEVICE WAS NOT RETURNED, ENTERED MANUFACTURE DATE: UPDATED THE EU/CA FIELDS ACCORDINGLY, AND UPDATED THE NARRATIVE. UPDATE (B)(4) 2013. ADDITIONAL INFORMATION RECEIVED FROM THE PRODUCT COMPLAINT SAFETY DATABASE. CORRECTED THE LOT NUMBER FOR PRODUCT (B)(4), ADDED THE LOT NUMBER FOR THE HUMULIN CARTRIDGE AND THE RETURN DATE OF THE PRODUCT, CORRECTED THE PRODUCT TO HUMAPEN LUXURA HD MODEL MS9673, UPDATED EU/CA FIELDS, MW FIELDS, AND THE NARRATIVE. UPDATE (B)(4) 2013: UPON REVIEW OF THE CASE ON (B)(4) 2013 ON INFORMATION PROVIDED ON (B)(4) 2013: CASE WAS OPENED TO UPDATE THE CODING OF THE DEVICE FROM A HUMAPEN LUXURA HD DEMO TO A HUMAPEN LUXURA HD. ADDITIONALLY, UPON CLARIFICATION RECEIVED FROM CALL CENTER ON (B)(4) 2013, ADDED CONFLICTING INFORMATION ABOUT THE DEVICE. NARRATIVE AND CORRESPONDING FIELDS WERE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS SPONTANEOUS DEVICE CASE, REPORTED BY CONSUMER, WHO CONTACTED THE COMPANY TO REPORT AN ADVERSE EVENT, CONCERNS AN (B)(6) FEMALE LIGHT BROWN PATIENT. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED HUMAN INSULIN RDNA ORIGIN (HUMULIN 70N/30R; LOT NUMBER C014790J) CARTRIDGES, UNKNOWN DOSES AND FREQUENCY, SUBCUTANEOUSLY, FOR TREATMENT OF TYPE II DIABETES, BEGINNING IN 1998. ON AN UNKNOWN DATE, SHE STARTED TO RECEIVE HUMAN INSULIN VIA HUMAPEN LUXURA HALF DOSE (HD). ON (B)(6) 2013, APPROXIMATELY 15 YEAR AFTER THE BEGINNING OF THE TREATMENT HUMAN INSULIN RDNA ORIGIN, THE PATIENT EXPERIENCED HYPOGLYCEMIC COMA DUE TO THE HUMAPEN LUXURA HD WAS INJECTING THE DRUG IN AN UNCONTROLLED WAY (PRODUCT COMPLAINT NUMBER (B)(4) FOR LOT NUMBER 1012G01; MANUFACTURER DATE DEC2010). CONFLICTING INFORMATION WAS REPORTED BECAUSE PATIENT HAD THREE OR FOUR DEVICES HUMAPEN LUXURA HD (PRODUCT COMPLAINT NUMBER (B)(4) FOR LOT NUMBER 0803B03 WAS CANCELLED) (UNSPECIFIED IF THEY WERE ALL LILLY DEVICES) AND REPORTER WAS UNSURE WHAT DEVICE WAS USED AT THE TIME OF THE EVENT. HOWEVER, UPON FOLLOW UP, ACCORDING TO THE REPORTER, THE DEVICE THAT WAS RETURNED (LOT NUMBER 1012G01) WAS THE CLAIMED DEVICE. NO MALFUNCTION WAS IDENTIFIED. THE EVENT HYPOGLYCEMIC COMA WAS CONSIDERED SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. ON 17-MAR-2013 THE PATIENT RECOVERED FROM HYPOGLYCEMIC COMA. INFORMATION ABOUT CORRECTIVE TREATMENT WAS UNKNOWN. THE DOSE OF HUMAN INSULIN WAS REDUCED TO AVOID HYPOGLYCEMIA. ON (B)(6) 2013 THE PATIENT WAS APPLYING THE MEDICATION IN HERSELF, WITH THE SAME HUMAPEN LUXURA HD, AND REALIZED THAT THE MEDICATION WAS NOT RELEASED. THE PATIENT CHANGED TO ANOTHER DEVICE TO PERFORM THE APPLICATION AND COULD RECEIVE HUMAN INSULIN NORMALLY. THE TREATMENT WITH INSULIN RDNA ORIGIN WAS CONTINUED. THE PATIENT WAS OPERATED THE UNTRAINED OPERATOR OF THE DEVICE. THEY HAD USED THIS DEVICE MODEL AND THE REPORTED FOR UNSPECIFIED TIME. THE DEVICE WAS RETURNED ON 04JUN2013. THE CONSUMER DID NOT PROVIDE AN OPINION OF RELATEDNESS BETWEEN THE EVENTS AND INSULIN RDNA ORIGIN BUT STATED THE EVENT OF HYPOGLYCEMIC COMA WAS RELATED TO THE DEVICE. EDIT 03-APR-2013: UPON INTERNAL REVIEW, IT WAS UPDATED NARRATIVE WITH PATIENT GENDER. UPDATE 30MAY2013. ADDITIONAL INFORMATION RECEIVED 30MAY2013 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. ADDED LOT NUMBER 0803B03 FOR PRODUCT COMPLAINT (B)(4); ON DEVICE PRODUCT PAGE CODED THE DEVICE TO HUMAPEN LUXURA, CHAMPAGNE (FROM BODY TYPE UNKNOWN) MODEL NUMBER MS9663, CHANGED IMPROPER USE TO YES, NOTED DEVICE WAS NOT RETURNED, ENTERED MANUFACTURE DATE: UPDATED THE EU/CA FIELDS ACCORDINGLY, AND UPDATED THE NARRATIVE. UPDATE 10JUN2013. ADDITIONAL INFORMATION RECEIVED FROM THE PRODUCT COMPLAINT SAFETY DATABASE. CORRECTED THE LOT NUMBER FOR PRODUCT COMPLAINT (B)(4) FROM 0803B03 TO 1012G01, ADDED THE LOT NUMBER FOR THE HUMULIN CARTRIDGE AND THE RETURN DATE OF THE PRODUCT, CORRECTED THE PRODUCT TO HUMAPEN LUXURA HD MODEL MS9673, UPDATED EU/CA FIELDS, MW FIELDS, AND THE NARRATIVE. UPDATE 14-JUN-2013: UPON REVIEW OF THE CASE ON 14JUN2013 ON INFORMATION PROVIDED ON 07JUN2013: CASE WAS OPENED TO UPDATE THE CODING OF THE DEVICE FROM A HUMAPEN LUXURA HD DEMO TO A HUMAPEN LUXURA HD. ADDITIONALLY, UPON CLARIFICATION RECEIVED FROM CALL CENTER ON 12JUN2013, ADDED CONFLICTING INFORMATION ABOUT THE DEVICE. NARRATIVE AND CORRESPONDING FIELDS WERE UPDATED ACCORDINGLY. UPDATE 17-JUN-2013: ADDITIONAL INFORMATION RECEIVED FROM CALL CENTER ON 14-JUN-2013. NO MEDICALLY SIGNIFICANT INFORMATION WAS RECEIVED. UPDATE 08JUL2013. ADDITIONAL INFORMATION RECEIVED 03JUL2013 PRODUCT COMPLAINT SAFETY DATABASE. UPDATED DEVICE SPECIFIC SAFETY SUMMARY; ON DEVICE PRODUCT PAGE CORRECTED MANUFACTURED DATE OF LOT 1012G01 TO DEC2010 FROM MAR2008; ENTERED OPERATOR WAS UNTRAINED, NOTED NO MALFUNCTION WAS IDENTIFIED; PC (B)(4) WAS CANCELLED; UPDATED THE CAUSALITY ON EVENT PAGE TO NOT REPORTED FOR THE INSULIN, UPDATED EU/CA, MEDWATCH FIELDS ACCORDINGLY, AND UPDATED THE NARRATIVE. UPDATE 11JUL2013. EDIT TO EU/CA FIELD. MOVED NOTATION FROM THE GENERAL COMMENT FIELD TO THE MANUFACTURES FINAL COMMENT FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271143 HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9673 1012G01

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other HUMULIN 70/30