BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN SAVVIO 3ML (GREEN)

    MDR report key: 6158301 · Received December 9, 2016

    Report

    Report Number
    1819470-2016-00324
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K160668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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 REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION HAS BEEN COMPLETED. THIS REPORT IS ASSOCIATED WITH 1819470-2016-0325, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED.

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. THIS REPORT IS ASSOCIATED WITH 1819470-2016-0325, SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED. EVALUATION SUMMARY: THE DAUGHTER OF A FEMALE PATIENT REPORTED HER MOTHER'S HUMAPEN SAVVIO DEVICE NEVER WORKED AND DID NOT RELEASE INSULIN. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL HUMAPEN SAVVIO DEVICES ARE ASSESSED FOR INJECTION SCREW TRAVEL AT THE END OF THE MANUFACTURING PROCESS, THUS ENSURING DEVICE FUNCTIONALITY AND DOSE ACCURACY WITH HIGH PROBABILITY. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS, CONCERNED A (B)(4) FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED BEING DIABETIC FOR 28 YEARS (SINCE 1988). CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO PROTAMINE SUSPENSION 75%/INSULIN LISPRO 25% (RDNA ORIGIN) INJECTION (HUMALOG MIX 25) FROM CARTRIDGE BEGINNING APPROXIMATELY IN 2011 VIA REUSABLE PEN (HUMAPEN SAVVIO; RED AND GREEN); DOSAGE REGIMEN AND INDICATION FOR USE WERE UNKNOWN. APPROXIMATELY IN (B)(6) 2016 THE TWO HUMAPENS SAVVIO (1ST; UNKNOWN LOT NUMBER AND PC NUMBER. 2ND UNKNOWN LOT NUMBER AND PC) NEVER WORKED AND NEVER GOT ANY INSULIN FROM THEM. SOMETIME IN (B)(6) 2016 WHILE ON INSULIN LISPRO 75/25, SHE HAD A FLU OR COLD. ON UNKNOWN DATE, SHE POSSIBLE DID NOT GET THE ENOUGH INSULIN LISPRO OR MAYBE GET AN INFECTION AND HER BLOOD GLUCOSE LEVELS WERE VERY HIGH. ON (B)(6) 2016 SHE WAS HOSPITALIZED BECAUSE SHE BANGED HER HEAD DURING A FALL AND WENT INTO COMA. SHE WAS DISCHARGED ON (B)(6) 2016. INFORMATION REGARDING THE OUTCOME OF THE EVENTS, CORRECTIVE TREATMENT WAS NOT PROVIDED. INSULIN LISPRO 75/25 WAS ONGOING. THE OPERATOR OF THE DEVICE WAS THE PATIENT AND HER TRAINING STATUS WAS UNKNOWN. THE GENERAL DEVICE AND THE REPORTED DEVICE DURATION OF USE WERE UNKNOWN. THE ACTION TAKEN WITH THE DEVICES WERE UNKNOWN; THEIR RETURN WAS EXPECTED. THE REPORTING CONSUMER DID NOT RELATE THE EVENTS TO INSULIN LISPRO. NO FOLLOW UP COULD BE POSSIBLE SINCE THE REPORTING CONSUMER DECLINED TO BE FURTHER CONTACT. NO HCP CONTACT DETAILS WERE PROVIDED. EDIT 01DEC2016. CASE WAS OPENED TO ENTER MEDWATCH DEVICE FIELDS FIELDS FOR DEVICE MAILING. NO NEW INFORMATION.

    Description of Event or Problem · 1

    (B)(6). THIS CASE IS ASSOCIATED WITH PRODUCT COMPLAINT NUMBER: (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT ADVERSE EVENTS, CONCERNED A (B)(6) FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED BEING DIABETIC FOR (B)(6) (SINCE 1988). CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO PROTAMINE SUSPENSION 75%/INSULIN LISPRO 25% (RDNA ORIGIN) INJECTION (HUMALOG MIX 25) FROM CARTRIDGE BEGINNING APPROXIMATELY IN 2011 VIA REUSABLE PEN (HUMAPEN SAVVIO; RED AND GREEN); DOSAGE REGIMEN AND INDICATION FOR USE WERE UNKNOWN. APPROXIMATELY IN (B)(6) 2016 THE TWO HUMAPENS SAVVIO (RED; UNKNOWN LOT NUMBER AND PC NUMBER 3846258) (GREEN UNKNOWN LOT NUMBER AND PC (B)(4)) NEVER WORKED AND NEVER GOT ANY INSULIN FROM THEM. SOMETIME IN (B)(6) 2016 WHILE ON INSULIN LISPRO 75/25, SHE HAD A FLU OR COLD. ON UNKNOWN DATE, SHE POSSIBLY DID NOT GET THE ENOUGH INSULIN LISPRO OR MAYBE GET AN INFECTION AND HER BLOOD GLUCOSE LEVELS WERE VERY HIGH. ON (B)(6) 2016, SHE WAS HOSPITALIZED BECAUSE SHE BANGED HER HEAD DURING A FALL AND WENT INTO COMA. SHE WAS DISCHARGED ON (B)(6) 2016. INFORMATION REGARDING THE OUTCOME OF THE EVENTS, CORRECTIVE TREATMENT WAS NOT PROVIDED. INSULIN LISPRO 75/25 WAS ONGOING. THE OPERATOR OF THE DEVICE WAS THE PATIENT AND HER TRAINING STATUS WAS UNKNOWN. THE GENERAL DEVICE AND THE REPORTED DEVICE DURATION OF USE WERE UNKNOWN. THE DEVICES WERE NOT RETURNED. THE REPORTING CONSUMER DID NOT RELATE THE EVENTS TO INSULIN LISPRO. UPDATE 27DEC2016. ADDITIONAL INFORMATION RECEIVED 25DEC2016 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. (B)(4). NO FOLLOW UP COULD BE POSSIBLE SINCE THE REPORTING CONSUMER DECLINED TO BE FURTHER CONTACT. NO HCP CONTACT DETAILS WERE PROVIDED. EDIT 01DEC2016. CASE WAS OPENED TO ENTER MEDWATCH DEVICE FIELDS FOR DEVICE MAILING. NO NEW INFORMATION. UPDATE 12-DEC-2016: PC NUMBER (B)(4) WAS RECEIVED FROM AFFILIATE. NO FURTHER CHANGES WERE PERFORMED TO THE CASE. UPDATE 27DEC2016. ADDITIONAL INFORMATION RECEIVED 25DEC2016 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. (B)(4). NO OTHER CHANGED WERE DONE. UPDATE 09JAN2017: ADDITIONAL INFORMATION RECEIVED ON 25DEC2016 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811521 HUMAPEN SAVVIO 3ML (GREEN) FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9696

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization HUMALOG