BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA HALF-DOSE PEN

    MDR report key: 4162482 · Received October 10, 2014

    Report

    Report Number
    1819470-2014-00059
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K063151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY THE PATIENT EXPERIENCED HIGH BLOOD SUGAR OF 500 AND USED A HUMAPEN LUXURA HD DEVICE (REPORTED LOT NUMBER 1009G01). THERE WAS NO PRODUCT COMPLAINT FOR THE DEVICE AND THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS EVIDENCE OF IMPROPER USE OF THE DEVICE. IT WAS REPORTED THAT THE PATIENT USED ONE NEEDLE PER DAY WHICH MAY LEAD TO UNDER DELIVERY OF INSULIN IF THE NEEDLE BECOMES CLOGGED. THIS MAY NOT BE RELEVANT TO THE REPORTED HIGH BLOOD SUGAR LEVELS GIVEN THAT THERE WAS NO COMPLAINT REGARDING INJECTION FORCES. THE DEVICE USER MANUAL INDICATES A NEW NEEDLE SHOULD BE USED WITH EACH INJECTION.

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED. 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, CONCERNS A (B)(64, BROWN, MALE PATIENT. THE MEDICAL HISTORY OF THE PATIENT INCLUDED: WEIGHT LOSS RELATED TO DIABETES. THE CONCOMITANT MEDICATION INCLUDED: INSULIN GLARGINE FOR UNKNOWN INDICATION OF USE. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) VIA HUMAPEN LUXURA HD, THE DOSE WAS ACCORDING TO HIS BLOOD GLUCOSE LEVELS BEFORE THE MEALS, WHEREIN THAT, THE MINIMUM DOSE WAS 1IU AND MAXIMUM WAS 2IU AND HALF IF BLOOD GLUCOSE WAS ABOVE 350 (UNKNOWN UNITS), THE FREQUENCY REPORTED AS NEEDED ACCORDING TO THE BLOOD GLUCOSE LEVEL, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON (B)(6) 2014. ON (B)(6) 2014, TWO DAYS AFTER STARTING THE INSULIN LISPRO TREATMENT VIA HUMAPEN LUXURA HD (LOT 1009G01), THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE LEVEL OF MEASURED AS 500 (RANGE AND UNITS NOT PROVIDED), WHICH WAS CONSIDERED SERIOUS DUE TO ITS MEDICAL SIGNIFICANCE. THE PATIENT DID NOT UNDERGO LABORATORY TEST, HOWEVER THE BLOOD GLUCOSE LEVEL WAS ALWAYS MEASURED BEFORE EACH MEAL. THE PATIENT RECEIVED 2,5IU OF INSULIN LISPRO AS A CORRECTIVE TREATMENT FOR THE HIGH BLOOD GLUCOSE LEVEL, AS CONSEQUENCE, THE BLOOD GLUCOSE DECREASED FOR 400 (UNITS NOT PROVIDED) BUT, ACCORDING TO REPORTER, THIS WAS A HIGH VALUE. THE PATIENT USED ONE NEEDLE FOR EACH DAY. THE INSULIN LISPRO THERAPY WAS CONTINUED. THE MOTHER OF THE PATIENT WAS THE OPERATOR OF THE DEVICE AND SHE WAS TRAINED AT THE DRUGSTORE. THE DEVICE HAD BEEN USED FOR ONLY THREE DAYS. THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED THE REPORTING CONSUMER STATED THAT THE EVENT WAS NOT RELATED TO THE INSULIN LISPRO THERAPY. UPDATE 01-OCT-2014. FOLLOW UP RECEIVED ON (B)(6) 2014 FROM INITIAL REPORTING CONSUMER. ADDED ETHNICITY, INFORMATION REGARDING THE DOSE AND LABORATORY TEST. ALL CORRESPONDENTS FIELDS WERE UPDATED.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, CONCERNS A (B)(6), BROWN, MALE PATIENT. THE MEDICAL HISTORY OF THE PATIENT INCLUDED: WEIGHT LOSS RELATED TO DIABETES. THE CONCOMITANT MEDICATION INCLUDED: INSULIN GLARGINE FOR UNKNOWN INDICATION OF USE. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) VIA HUMAPEN LUXURA HD, THE DOSE WAS ACCORDING TO HIS BLOOD GLUCOSE LEVELS BEFORE THE MEALS, WHEREIN THAT, THE MINIMUM DOSE WAS 1IU AND MAXIMUM WAS 2IU AND HALF IF BLOOD GLUCOSE WAS ABOVE 350 (UNKNOWN UNITS), THE FREQUENCY REPORTED AS NEEDED ACCORDING TO THE BLOOD GLUCOSE LEVEL, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON (B)(6) 2014. ON (B)(6) 2014, TWO DAYS AFTER STARTING THE INSULIN LISPRO TREATMENT VIA HUMAPEN LUXURA HD (LOT 1009G01), THE PATIENT EXPERIENCED INCREASED BLOOD GLUCOSE LEVEL OF MEASURED AS 500 (RANGE AND UNITS NOT PROVIDED), WHICH WAS CONSIDERED SERIOUS DUE TO ITS MEDICAL SIGNIFICANCE. THE PATIENT DID NOT UNDERGO LABORATORY TEST, HOWEVER THE BLOOD GLUCOSE LEVEL WAS ALWAYS MEASURED BEFORE EACH MEAL. THE PATIENT RECEIVED 2,5IU OF INSULIN LISPRO AS A CORRECTIVE TREATMENT FOR THE HIGH BLOOD GLUCOSE LEVEL, AS CONSEQUENCE, THE BLOOD GLUCOSE DECREASED FOR 400(UNITS NOT PROVIDED) BUT, ACCORDING TO REPORTER, THIS WAS A HIGH VALUE. THE PATIENT USED ONE NEEDLE FOR EACH DAY. THE INSULIN LISPRO THERAPY WAS CONTINUED. THE MOTHER OF THE PATIENT WAS THE OPERATOR OF THE DEVICE AND SHE WAS TRAINED AT THE DRUGSTORE. THE DEVICE HAD BEEN USED FOR ONLY THREE DAYS. THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND THE DEVICE WAS NOT RETURNED. THE REPORTING CONSUMER STATED THAT THE EVENT WAS NOT RELATED TO THE INSULIN LISPRO THERAPY. UPDATE 01-OCT-2014. FOLLOW UP RECEIVED ON 26-SEP-2014 FROM INITIAL REPORTING CONSUMER. ADDED ETHNICITY, INFORMATION REGARDING THE DOSE AND LABORATORY TEST. ALL CORRESPONDENTS FIELDS WERE UPDATED. UPDATE 30-OCT-2014: ADDITIONAL INFORMATION RECEIVED ON 30-OCT-2014 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND THAT THE DEVICE WAS NOT RETURNED; UPDATED THE EU/ CA FIELDS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640547 HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9673A 1009G01

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other LANTUS| HUMALOG (LISPRO)