BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA HALF-DOSE PEN

    MDR report key: 5192039 · Received October 30, 2015

    Report

    Report Number
    1819470-2015-00102
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    September 30, 2015
    Report Date
    October 15, 2015
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    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

    SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY: A MALE PATIENT REPORTED THAT HIS HUMAPEN LUXURA HD DEVICE SOMETIMES DID NOT RELEASE HIS INSULIN DOSE AND THE EJECTION OF INSULIN FROM HIS HUMAPEN LUXURA DEVICE WAS TWICE AS FAST AS THE EJECTION OF HIS HUMAPEN LUXURA HD DEVICE FOR THE SAME DOSE. THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE LEVELS. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH 1401G10, MANUFACTURED JANUARY 2014). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL HUMAPEN LUXURA HD DEVICES ARE ASSESSED FOR INJECTION SCREW TRAVEL AT THE END OF THE MANUFACTURING PROCESS, THUS ENSURING DOSE ACCURACY. A COMPLAINT HISTORY REVIEW OF THIS BATCH DID NOT IDENTIFY ANY ATYPICAL TRENDS WITH REGARD TO DOSE ACCURACY. THE DOSE KNOB ON A HUMAPEN LUXURA HD DEVICE WILL DIAL OUT A FARTHER DISTANCE THAN THE DOSE KNOB ON A HUMAPEN LUXURA DEVICE WHEN DIALED TO THE SAME DOSE. THIS MAY EXPLAIN THE PERCEPTION OF THE PATIENT THAT HIS HUMAPEN LUXURA HD DEVICE TAKES LONGER TO EJECT AT THE SAME DOSE AS HIS HUMAPEN LUXURA DEVICE. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE REPORTED BY A CONSUMER VIA CALL CENTER WHO CONTACTED THE COMPANY TO NOTIFY A PRODUCT COMPLAIN CONCERNS A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDE EMPAGLIFLOZIN FOR UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED HUMAN INSULIN (RDNA ORIGIN) NPH (HUMULIN N) CARTRIDGE, WITH UNKNOWN DOSE, FREQUENCY, ROUTE OF ADMINISTRATIONS, FOR DIABETES TREATMENT, BEGINNING IN 2008. ON AN UNSPECIFIED DATE, UNKNOWN TIME AFTER COMMENCING HUMAN INSULIN NPH TREATMENT VIA HUMAPEN LUXURA UNKNOWN PEN BODY TYPE, THE REPORTING CONSUMER STATED THAT THE HUMAN INSULIN NPH WAS NOT MAKING ANY EFFECT ON THE PATIENT ANYMORE. DUE THAT THE PATIENT PHYSICIAN CHANGED THE HUMAN INSULIN NPH TO INSULIN LISPRO 50% LISPRO, 50% NPL. ON ANOTHER UNSPECIFIED DATE, UNKNOWN IF WHILST ON HUMAN INSULIN NPH OR INSULIN LISPRO 50% LISPRO, 50% NPL, THE REPORTING CONSUMER STATED THAT THE PATIENT WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AFTER THE MEALS. THE PATIENT BLOOD GLUCOSE WAS USUALLY AT 140 WHEN HE ATE TOO MUCH. CORRECTIVE TREATMENT WAS NOT PROVIDED. THE PATIENT RECOVERS FROM THE EVENT ON AN UNKNOWN DATE. IN (B)(6) 2015, WHILST INJECTING INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT VIA SYRINGE, THE PATIENT WAS EXPERIENCING PAIN ON THE INJECTION SITE. LABORATORY EXAMS WERE NOT PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT STARTED TO USE INSULIN LISPRO 50% LISPRO, 50% NPL VIA HUMAPEN LUXURA HALF-DOSE ( BATCH: C304087). THE REPORTING CONSUMER STATED THAT THE PATIENT RECOVER FROM THE EVENT. ON (B)(6) 2015, WHILST ON USE INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT, THE PATIENT HUMAPEN LUXURA HALF-DOSE JAMMED AND WAS NOT DELIVERING THE DOSE AND DUE THAT THE BLOOD GLUCOSE WAS VERY HIGH AND THE REPORTER STATED THAT THE PATIENT WAS ALMOST HOSPITALIZED DUE THAT. THE PATIENT BLOOD GLUCOSE LEVELS WERE 500, NO UNITS PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT USED THE HUMAPEN LUXURA UNKNOWN BODY TYPE THAT HE ALREADY HAD AND INJECTED AN UNSPECIFIED DOSE, AS REPORTED AS BETWEEN 45 AND 50IU. THE EVENT OF BLOOD GLUCOSE WAS 500 WAS CONSIDERED SERIOUS BY THE COMPANY DUE MEDICALLY SIGNIFICANT REASONS. THE REPORTING CONSUMER STATED THAT THE PATIENT WAS RECOVERING FROM THE EVENT. INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT WAS CONTINUED. THE PATIENT WAS THE OPERATOR OF THE HUMAPEN LUXURA UNKNOWN BODY TYPE. IT WAS UNKNOWN IF HE WAS PROPERLY TRAINED. IT WAS UNKNOWN FOR HOW LONG HE USES THE HUMAPEN LUXURA UNKNOWN BODY TYPE DEVICE OR THE DEVICE MODEL AND THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED. HE WAS ALSO THE OPERATOR OF THE HUMAPEN LUXURA HALF DOSE AND WAS ALSO PROPERLY TRAINED BY A NURSE. THE PATIENT STARTED TO USE THE SUSPECT DEVICE MODEL AND THE SUSPECT DEVICE IN (B)(6) 2015. SINCE THE DEVICE IS NOT BEING RETURNED, AN EVALUATION IS NOT POSSIBLE. THE REPORTING CONSUMER RELATED THE LACK OF DRUG EFFECT TO HUMAN INSULIN NPH AND THE BLOOD GLUCOSE WAS HIGH AFTER THE MEALS TO INSULIN LISPRO 50% LISPRO, 50% NPL AND HUMAN INSULIN NPH AND RELATED THE BLOOD GLUCOSE WAS 500 AND INJECTION SITE PAIN TO INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT. UPDATE 22OCT2015: UPON REVIEW OF THIS CASE ON 22OCT2015, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING.

    Description of Event or Problem · 1

    (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLIANT: (B)(4). THIS SPONTANEOUS CASE REPORTED BY A CONSUMER VIA CALL CENTER WHO CONTACTED THE COMPANY TO NOTIFY A PRODUCT COMPLAIN CONCERNS A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDE EMPAGLIFLOZIN FOR UNKNOWN INDICATION FOR USE. THE PATIENT RECEIVED HUMAN INSULIN (RDNA ORIGIN) NPH (HUMULIN N) CARTRIDGE, WITH UNKNOWN DOSE, FREQUENCY, ROUTE OF ADMINISTRATIONS, FOR DIABETES TREATMENT, BEGINNING IN 2008. ON AN UNSPECIFIED DATE, UNKNOWN TIME AFTER COMMENCING HUMAN INSULIN NPH TREATMENT VIA HUMAPEN LUXURA UNKNOWN PEN BODY TYPE, THE REPORTING CONSUMER STATED THAT THE HUMAN INSULIN NPH WAS NOT MAKING ANY EFFECT ON THE PATIENT ANYMORE. DUE THAT THE PATIENT PHYSICIAN CHANGED THE HUMAN INSULIN NPH TO INSULIN LISPRO 50% LISPRO, 50% NPL. ON ANOTHER UNSPECIFIED DATE, UNKNOWN IF WHILST ON HUMAN INSULIN NPH OR INSULIN LISPRO 50% LISPRO, 50% NPL, THE REPORTING CONSUMER STATED THAT THE PATIENT WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AFTER THE MEALS. THE PATIENT BLOOD GLUCOSE WAS USUALLY AT 140 WHEN HE ATE TOO MUCH. CORRECTIVE TREATMENT WAS NOT PROVIDED. THE PATIENT RECOVERS FROM THE EVENT ON AN UNKNOWN DATE. IN (B)(6) 2015, WHILST INJECTING INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT VIA SYRINGE, THE PATIENT WAS EXPERIENCING PAIN ON THE INJECTION SITE. LABORATORY EXAMS WERE NOT PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT STARTED TO USE INSULIN LISPRO 50% LISPRO, 50% NPL VIA HUMAPEN LUXURA HALF-DOSE ( BATCH: 1401G10). THE REPORTING CONSUMER STATED THAT THE PATIENT RECOVER FROM THE EVENT. ON (B)(6) 2015, WHILST ON USE INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT, THE PATIENT HUMAPEN LUXURA HALF-DOSE JAMMED AND WAS NOT DELIVERING THE DOSE (PRODUCT COMPLAINT (B)(4)) AND DUE THAT THE BLOOD GLUCOSE WAS VERY HIGH AND THE REPORTER STATED THAT THE PATIENT WAS ALMOST HOSPITALIZED DUE THAT. THE PATIENT BLOOD GLUCOSE LEVELS WERE 500, NO UNITS PROVIDED. AS CORRECTIVE TREATMENT THE PATIENT USED THE HUMAPEN LUXURA UNKNOWN BODY TYPE THAT HE ALREADY HAD AND INJECTED AN UNSPECIFIED DOSE, AS REPORTED AS BETWEEN 45 AND 50IU. THE EVENT OF BLOOD GLUCOSE WAS 500 WAS CONSIDERED SERIOUS BY THE COMPANY DUE MEDICALLY SIGNIFICANT REASONS. THE REPORTING CONSUMER STATED THAT THE PATIENT WAS RECOVERING FROM THE EVENT. INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT WAS CONTINUED. THE PATIENT WAS THE OPERATOR OF THE HUMAPEN LUXURA UNKNOWN BODY TYPE. IT WAS UNKNOWN IF HE WAS PROPERLY TRAINED. IT WAS UNKNOWN FOR HOW LONG HE USES THE HUMAPEN LUXURA UNKNOWN BODY TYPE DEVICE OR THE DEVICE MODEL AND THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED. HE WAS ALSO THE OPERATOR OF THE HUMAPEN LUXURA HALF DOSE AND WAS ALSO PROPERLY TRAINED BY A NURSE. THE PATIENT STARTED TO USE THE SUSPECT DEVICE MODEL AND THE SUSPECT DEVICE IN (B)(6) 2015. THE DEVICE WAS NOT RETURNED. THE REPORTING CONSUMER RELATED THE LACK OF DRUG EFFECT TO HUMAN INSULIN NPH AND THE BLOOD GLUCOSE WAS HIGH AFTER THE MEALS TO INSULIN LISPRO 50% LISPRO, 50% NPL AND HUMAN INSULIN NPH AND RELATED THE BLOOD GLUCOSE WAS 500 AND INJECTION SITE PAIN TO INSULIN LISPRO 50% LISPRO, 50% NPL TREATMENT. UPDATE 22OCT2015: UPON REVIEW OF THIS CASE ON 22OCT2015, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 03NOV2015: ADDITIONAL INFORMATION WAS RECEIVED ON 02NOV2015 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER C304087 WAS CORRECTED TO 1401G10 FOR PRODUCT COMPLAINT (B)(4). THE PRODUCT TAB FOR HUMAPEN LUXURA HALF-DOSE AND THE NARRATIVE WERE UPDATED WITH THE CHANGE. UPDATE 12NOV2015: ADDITIONAL INFORMATION RECEIVED ON 12NOV2015 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATE OF THE DEVICE; ADDED THE DEVICE WAS NOT RETURNED; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722670 HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9673 1401G10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other