BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA BURGUNDY

    MDR report key: 6061628 · Received October 27, 2016

    Report

    Report Number
    1819470-2016-00270
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 5, 2016
    Report Date
    February 1, 2016
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K142518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NARRATIVE - NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS IN DESCRIBE EVENT OR PROBLEM. PLEASE REFER TO UPDATE STATEMENT DATED 08NOV2016 IN DESCRIBE EVENT OR PROBLEM. NO FURTHER FOLLOW UP IS PLANNED.

    Description of Event or Problem · 1

    (B)(4). THIS SOLICITED CASE, REPORTED BY A PHARMACIST VIA PATIENT SUPPORT PROGRAM (PSP) WITH ADDITIONAL INFORMATION PROVIDED BY A CONSUMER, CONCERNS A CAUCASIAN MALE PATIENT BORN ON (B)(6). MEDICAL HISTORY: PACEMAKER INSERTION IN 2001. CONCOMITANT MEDICATION: UNSPECIFIED MEDICATION CALLED AS PREZIMA FOR DIABETES; DOXAZOSIN FOR THE BLADDER; SIMETHICONE FOR GAS AND PANTOPRAZOLE SODIUM SESQUIHYDRATE FOR THE STOMACH. THE PATIENT RECEIVED INSULIN 25% LISPRO+ 75% NPL (HUMALOG MIX 25) CARTRIDGE, 5 IU IF GLYCEMIA WAS UNDER 200 (UNIT AND NORMAL RANGE NOT PROVIDED), INITIAL DOSE OF 5 IU + 2 IU IF GLYCEMIA WAS BETWEEN 200 AND 250; INITIAL DOSE OF 5 IU + 4 IU IF IT WAS BETWEEN 250 AND 300 AND INITIAL DOSE OF 5 IU + 6 IU IF IT WAS BETWEEN 300 AND 350, ALSO, AT LUNCH TIME THE INITIAL DOSE WAS REPORTED AS 8 IU; THREE TO FOUR TIMES A DAY; UNKNOWN ADMINISTRATION ROUTE, FOR THE TREATMENT OF DIABETES, BEGINNING ON AN UNSPECIFIED DATE. IT WAS UNKNOWN HOW INSULIN 25% LISPRO+ 75% NPL WAS DELIVERED IN THE BEGINNING OF THERAPY. ON A NON-REPORTED DATE, UNKNOWN TIME AFTER STARTING TREATMENT WITH INSULIN 25% LISPRO + 75% NPL, THE DRUGSTORE DISPENSED INCORRECTLY TWO CARTRIDGES OF INSULIN LISPRO (HUMALOG) INSTEAD OF INSULIN 25% LISPRO + 75% NPL. THE PATIENT NOTICED THE DISPENSING ERROR AND RETURNED TO THE DRUGSTORE TO GIVE BACK THE WRONG INSULIN. IT WAS REPORTED THE PATIENT DID NOT USE THE INSULIN LISPRO. ON AN UNSPECIFIED DATE, THE PATIENT STARTED TO USE HUMAPEN SAVVIO (UNKNOWN BODY TYPE) TO DELIVER INSULIN 25% LISPRO+ 75% NPL, AND IN (B)(6) 2016 HE ALSO STARTED TO USE HUMAPEN LUXURA BURGUNDY TO DELIVER INSULIN, HOWEVER IT WAS UNKNOWN IF THE PATIENT USED BOTH DEVICES CONCOMITANTLY OR NOT. MOREOVER, IT WAS STATED THAT THE CARTRIDGE OF INSULIN 25% LISPRO+ 75% NPL WAS TAKEN OUT OF THE DEVICE AND STORED IN THE REFRIGERATOR. THE CORRECTIVE MEASURES AND THE OUTCOME FOR DISPENSING ERROR AND INCORRECT STORAGE OF DRUG WERE NOT PROVIDED. ON (B)(6) 2016 AT LUNCH TIME, THE PATIENT APPLIED INSULIN 25% LISPRO+ 75% NPL VIA HUMAPEN LUXURA BURGUNDY, HOWEVER EVEN AFTER APPLICATION HIS DIABETES INCREASED, WHICH WAS DESCRIBED AS GLYCEMIA REACHED MORE THAN 600 (UNIT AND NORMAL RANGE WAS NOT PROVIDED) AND DUE TO THAT, THE PATIENT BELIEVED THAT INSULIN 25% LISPRO+ 75% NPL WAS NOT HAVING ANY EFFECT. THE EVENT OF DIABETES INCREASED WAS CONSIDERED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON BY THE COMPANY. AS CORRECTIVE TREATMENT THE PATIENT RECEIVED INSULIN 25% LISPRO + 75% NPL VIA KWIKPEN AND THEN HIS GLYCEMIA DECREASED, THEREFORE, THE PATIENT RECOVERED FROM HIGH GLYCEMIA. IT WAS REPORTED THAT PATIENT REUSED THE NEEDLES OF HUMAPEN LUXURA BURGUNDY. AT THE TIME OF REPORT THE INSULIN 25% LISPRO + 75% NPL THERAPY WAS ONGOING. THE HUMAPEN LUXURA BURGUNDY WAS OPERATED BY THE PATIENT AND HE WAS TRAINED BY A PHYSICIAN. THE HUMAPEN LUXURA BURGUNDY MODEL AND THE REPORTED HUMAPEN LUXURA BURGUNDY (LOT NUMBER 1307B06) WERE USED FOR FOUR MONTHS. THE RETURN OF DEVICE WAS NOT EXPECTED. THE PHARMACIST DID NOT PROVIDE ANY RELATEDNESS OPINION. THE REPORTING CONSUMER RELATED THE DIABETES INCREASED TO THE LACK OF EFFECT AND BOTH EVENTS WERE RELATED TO INSULIN 25% LISPRO+ 75% NPL THERAPY. THE REPORTING CONSUMER DID NOT PROVIDE ANY OTHER ASSESSMENT OF RELATEDNESS. THIS CASE IS CROSS-REFERENCED WITH THE CASE (B)(4) (SAME REPORTER). UPDATE 05FEB2016: ADDITIONAL INFORMATION RECEIVED ON 03FEB2016 FROM THE SAME INITIAL REPORTER WAS PROCESSED WITH THE INITIAL CASE. UPDATE 09SEP2016: ADDITIONAL INFORMATION FROM CONSUMER 08SEP2016. ADDED CONSUMER AS NEW REPORTER. UPDATED FORMULATION OF INSULIN 25% LISPRO + 75% NPL FROM UNKNOWN TO CARTRIDGE. ADDED NON-SERIOUS EVENT OF INCORRECT STORAGE OF DRUG. ADDED CONCOMITANT DEVICE HUMAPEN SAVVIO UNKNOWN COLOR. NARRATIVE AND CORRESPONDING FIELDS WERE UPDATED ACCORDINGLY. UPDATE 07OCT2016: ADDITIONAL INFORMATION WAS RECEIVED ON 05OCT2016 FROM THE SECOND REPORTING CONSUMER. ADDED CAUCASIAN AS ETHNICITY; ADDED BIRTH DATE OF PATIENT; ADDED MEDICAL HISTORY; ADDED CONCOMITANT MEDICATION; ADDED DOSE, FREQUENCY, INDICATION FOR USE AND START DATE OF INSULIN 25% LISPRO+ 75% NPL; ADDED HUMAPEN LUXURA BURGUNDY AS SUSPECT DEVICE; UPDATED THE HUMAPEN SAVVIO FROM CONCOMITANT TO SUSPECT DEVICE; ADDED DEVICE PARAGRAPH; ADDED DIABETES INCREASED AS SERIOUS ADVERSE EVENT; ADDED LACK OF EFFECT AS NON-SERIOUS ADVERSE EVENT; ADDED GLYCEMIA REACHED MORE THAN 600 AS LABORATORIAL EXAMINATION; ADDED INSULIN 25% LISPRO+ 75% NPL VIA KWIKPEN AS CORRECTIVE TREATMENT FOR DIABETES INCREASED; UPDATED STATUS OF INSULIN 25% LISPRO+ 75% NPL THERAPY; UPDATED ASSESSMENT OF RELATEDNESS. UPDATED NARRATIVE AND CORRESPONDING FIELDS ACCORDINGLY. EDIT 12OCT2016. CASE WAS OPENED TO ENTER MEDWATCH DEVICE FIELDS AND THE EUROPEAN/CANADIAN DEVICE FIELDS FOR DEVICE MAILING. NO NEW INFORMATION. EDIT 12OCT2016: UPON INTERNAL REVIEW ON 12OCT2016, THE HUMAPEN SAVVIO WAS CHANGED FROM SUSPECT TO CONCOMITANT. UPDATED NARRATIVE AND CORRESPONDING FIELDS ACCORDINGLY. EDIT 20OCT2016: UPON INTERNAL REVIEW ON 20OCT2016, THE ASSESSMENT OF RELATEDNESS IN NARRATIVE WAS UPDATED: THE CONSUMER WAS REMOVED FROM THE FIRST SENTENCE OF THIS PARAGRAPH, IN ORDER TO BE CONSISTENT WITH THE OTHER INFORMATION PROVIDED. ALSO, THE MEDICAL REVIEWER CORRECTED THE NAME OF SUSPECT DRUG IN THE LILLY ANALYSIS STATEMENT OF 19SEP2016. "26OCT2016". EDIT TO REMOVE REFERENCE TO THE SAVVIO DEVICE ON THE MEDWATCH FIELD FOR THE HP HUMAPEN LUXURA.

    Description of Event or Problem · 1

    (B)(4). THIS SOLICITED CASE, REPORTED BY A PHARMACIST VIA PATIENT SUPPORT PROGRAM (PSP) WITH ADDITIONAL INFORMATION PROVIDED BY A CONSUMER, CONCERNS A (B)(6) MALE PATIENT BORN ON (B)(6). MEDICAL HISTORY: PACEMAKER INSERTION IN 2001. CONCOMITANT MEDICATION: UNSPECIFIED MEDICATION CALLED AS PREZIMA FOR DIABETES; DOXAZOSIN FOR THE BLADDER; SIMETHICONE FOR GAS AND PANTOPRAZOLE SODIUM SESQUIHYDRATE FOR THE STOMACH. THE PATIENT RECEIVED INSULIN 25% LISPRO+ 75% NPL (HUMALOG MIX 25) CARTRIDGE, 5 IU IF GLYCEMIA WAS UNDER 200 (UNIT AND NORMAL RANGE NOT PROVIDED), INITIAL DOSE OF 5 IU + 2 IU IF GLYCEMIA WAS BETWEEN 200 AND 250; INITIAL DOSE OF 5 IU + 4 IU IF IT WAS BETWEEN 250 AND 300 AND INITIAL DOSE OF 5 IU + 6 IU IF IT WAS BETWEEN 300 AND 350, ALSO, AT LUNCH TIME THE INITIAL DOSE WAS REPORTED AS 8 IU; THREE TO FOUR TIMES A DAY; UNKNOWN ADMINISTRATION ROUTE, FOR THE TREATMENT OF DIABETES, BEGINNING ON AN UNSPECIFIED DATE. IT WAS UNKNOWN HOW INSULIN 25% LISPRO+ 75% NPL WAS DELIVERED IN THE BEGINNING OF THERAPY. ON A NON-REPORTED DATE, UNKNOWN TIME AFTER STARTING TREATMENT WITH INSULIN 25% LISPRO + 75% NPL, THE DRUGSTORE DISPENSED INCORRECTLY TWO CARTRIDGES OF INSULIN LISPRO (HUMALOG) INSTEAD OF INSULIN 25% LISPRO + 75% NPL. THE PATIENT NOTICED THE DISPENSING ERROR AND RETURNED TO THE DRUGSTORE TO GIVE BACK THE WRONG INSULIN. IT WAS REPORTED THE PATIENT DID NOT USE THE INSULIN LISPRO. ON AN UNSPECIFIED DATE, THE PATIENT STARTED TO USE HUMAPEN SAVVIO (UNKNOWN BODY TYPE) TO DELIVER INSULIN 25% LISPRO+ 75% NPL, AND IN (B)(6) 2016 HE ALSO STARTED TO USE HUMAPEN LUXURA BURGUNDY TO DELIVER INSULIN, HOWEVER IT WAS UNKNOWN IF THE PATIENT USED BOTH DEVICES CONCOMITANTLY OR NOT. MOREOVER, IT WAS STATED THAT THE CARTRIDGE OF INSULIN 25% LISPRO+ 75% NPL WAS TAKEN OUT OF THE DEVICE AND STORED IN THE REFRIGERATOR. THE CORRECTIVE MEASURES AND THE OUTCOME FOR DISPENSING ERROR AND INCORRECT STORAGE OF DRUG WERE NOT PROVIDED. ON (B)(6) 2016 AT LUNCH TIME, THE PATIENT APPLIED INSULIN 25% LISPRO+ 75% NPL VIA HUMAPEN LUXURA BURGUNDY, HOWEVER EVEN AFTER APPLICATION HIS DIABETES INCREASED, WHICH WAS DESCRIBED AS GLYCEMIA REACHED MORE THAN 600 (UNIT AND NORMAL RANGE WAS NOT PROVIDED) AND DUE TO THAT, THE PATIENT BELIEVED THAT INSULIN 25% LISPRO+ 75% NPL WAS NOT HAVING ANY EFFECT. THE EVENT OF DIABETES INCREASED WAS CONSIDERED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON BY THE COMPANY. AS CORRECTIVE TREATMENT THE PATIENT RECEIVED INSULIN 25% LISPRO + 75% NPL VIA KWIKPEN AND THEN HIS GLYCEMIA DECREASED, THEREFORE, THE PATIENT RECOVERED FROM HIGH GLYCEMIA. IT WAS REPORTED THAT PATIENT REUSED THE NEEDLES OF HUMAPEN LUXURA BURGUNDY. AT THE TIME OF REPORT THE INSULIN 25% LISPRO + 75% NPL THERAPY WAS ONGOING. THE HUMAPEN LUXURA BURGUNDY WAS OPERATED BY THE PATIENT AND HE WAS TRAINED BY A PHYSICIAN. THE HUMAPEN LUXURA BURGUNDY MODEL AND THE REPORTED HUMAPEN LUXURA BURGUNDY (LOT NUMBER 1307B06) WERE USED FOR FOUR MONTHS. THE DEVICE WAS NOT RETURNED. THE PHARMACIST DID NOT PROVIDE ANY RELATEDNESS OPINION. THE REPORTING CONSUMER RELATED THE DIABETES INCREASED TO THE LACK OF EFFECT AND BOTH EVENTS WERE RELATED TO INSULIN 25% LISPRO+ 75% NPL THERAPY. THE REPORTING CONSUMER DID NOT PROVIDE ANY OTHER ASSESSMENT OF RELATEDNESS. THIS CASE IS CROSS-REFERENCED WITH THE CASE (B)(4) (SAME REPORTER). UPDATE 05FEB2016: ADDITIONAL INFORMATION RECEIVED ON 03FEB2016 FROM THE SAME INITIAL REPORTER WAS PROCESSED WITH THE INITIAL CASE. UPDATE 09SEP2016: ADDITIONAL INFORMATION FROM CONSUMER 08SEP2016. ADDED CONSUMER AS NEW REPORTER. UPDATED FORMULATION OF INSULIN 25% LISPRO + 75% NPL FROM UNKNOWN TO CARTRIDGE. ADDED NON-SERIOUS EVENT OF INCORRECT STORAGE OF DRUG. ADDED CONCOMITANT DEVICE HUMAPEN SAVVIO UNKNOWN COLOR. NARRATIVE AND CORRESPONDING FIELDS WERE UPDATED ACCORDINGLY. UPDATE 07OCT2016: ADDITIONAL INFORMATION WAS RECEIVED ON 05OCT2016 FROM THE SECOND REPORTING CONSUMER. ADDED CAUCASIAN AS ETHNICITY; ADDED BIRTH DATE OF PATIENT; ADDED MEDICAL HISTORY; ADDED CONCOMITANT MEDICATION; ADDED DOSE, FREQUENCY, INDICATION FOR USE AND START DATE OF INSULIN 25% LISPRO+ 75% NPL; ADDED HUMAPEN LUXURA BURGUNDY AS SUSPECT DEVICE; UPDATED THE HUMAPEN SAVVIO FROM CONCOMITANT TO SUSPECT DEVICE; ADDED DEVICE PARAGRAPH; ADDED DIABETES INCREASED AS SERIOUS ADVERSE EVENT; ADDED LACK OF EFFECT AS NON-SERIOUS ADVERSE EVENT; ADDED GLYCEMIA REACHED MORE THAN 600 AS LABORATORIAL EXAMINATION; ADDED INSULIN 25% LISPRO+ 75% NPL VIA KWIKPEN AS CORRECTIVE TREATMENT FOR DIABETES INCREASED; UPDATED STATUS OF INSULIN 25% LISPRO+ 75% NPL THERAPY; UPDATED ASSESSMENT OF RELATEDNESS. UPDATED NARRATIVE AND CORRESPONDING FIELDS ACCORDINGLY. EDIT 12OCT2016. CASE WAS OPENED TO ENTER MEDWATCH DEVICE FIELDS AND THE EUROPEAN/CANADIAN DEVICE FIELDS FOR DEVICE MAILING. NO NEW INFORMATION. EDIT 12OCT2016: UPON INTERNAL REVIEW ON 12OCT2016, THE HUMAPEN SAVVIO WAS CHANGED FROM SUSPECT TO CONCOMITANT. UPDATED NARRATIVE AND CORRESPONDING FIELDS ACCORDINGLY. EDIT 20OCT2016: UPON INTERNAL REVIEW ON 20OCT2016, THE ASSESSMENT OF RELATEDNESS IN NARRATIVE WAS UPDATED: THE CONSUMER WAS REMOVED FROM THE FIRST SENTENCE OF THIS PARAGRAPH, IN ORDER TO BE CONSISTENT WITH THE OTHER INFORMATION PROVIDED. ALSO, THE MEDICAL REVIEWER CORRECTED THE NAME OF SUSPECT DRUG IN THE LILLY ANALYSIS STATEMENT OF 19SEP2016. ON "26OCT2016". EDIT TO REMOVE REFERENCE TO THE SAVVIO DEVICE ON THE MEDWATCH FIELD FOR THE HP HUMAPEN LUXURA. UPDATE 08NOV2016: ADDITIONAL INFORMATION RECEIVED ON 08NOV2016 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 EUROPEAN AND CANADIAN REQUIRED DEVICE REPORTING ELEMENTS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713416 HUMAPEN LUXURA BURGUNDY FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9662 1307B06

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other DOXAZOSINA| HUMAPEN SAVVIO 3ML (UNKNOWN COLOR)| INSULIN LISPRO| INSULIN LISPRO CARTRIDGE| PANTOPRAZOL| SIMETICONA