BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO II

    MDR report key: 10817652 · Received November 10, 2020

    Report

    Report Number
    1819470-2020-00156
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    October 19, 2020
    Report Date
    October 21, 2020
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K151686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE FIELD: NEW, UPDATED, AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED 06NOV2020. NO FURTHER FOLLOW-UP IS PLANNED. THIS REPORT IS ASSOCIATED WITH 1819470-2020-00155 SINCE THERE IS MORE THAN ONE DEVICE IMPLICATED. EVALUATION SUMMARY: A FEMALE PATIENT REPORTED THAT THE BLACK INJECTION SCREW OF HER HUMAPEN ERGO II DEVICE "DID NOT MOVE, SOMETIMES THE INJECTION BUTTON COULD NOT BE PRESSED DOWN AND SOMETIMES THE INJECTION BUTTON COULD ONLY BE PRESSED DOWN A LITTLE AND INSULIN COULD NOT BE EJECTED OUT." THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH NUMBER UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. ALL HUMAPEN ERGO II 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

    LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLAINT: 5339263. THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER, CONCERNS A (B)(6) YEAR OLD FEMALE PATIENT WITH ETHNICITY REPORTED AS (B)(6). INFORMATION REGARDING MEDICAL HISTORY OF PATIENT WAS NOT PROVIDED, CONCOMITANT MEDICATIONS INCLUDED METIFORMIN,PANCREATIC KININOGENASE AND HUMAN INSULIN, ALL FOR UNKNOWN INDICATION. THE PATIENT RECEIVED INSULIN LISPRO 25% + INSULIN LISPRO NPL 75% (RDNA ORIGIN) (HUMALOG MIX 25) FROM CARTRIDGES, UNKNOWN DOSE AND FREQUENCY, SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON AN UNKNOWN DATE REPORTED AS MANY YEARS BEFORE (B)(6) 2020. ON AN UNSPECIFIED DATE, THE PATIENT STARTED DELIVERING THE INSULIN LISPRO +INSULIN LISPRO NPL VIA TWO HUMAPEN ERGO II DEVICES (REPORTED AS BLUE). ON UNKNOWN DATE, PATIENT CHANGED DOSE AND FREQUENCY OF INSULIN LISPRO + INSULIN LISPRO NPL BY HERSELF TO 24 AT MORNING AND 24 AT NIGHT (UNITS NOT PROVIDED). IT WAS REPORTED THAT SINCE AN UNKNOWN DATE (PROVIDED AS CURRENT TO (B)(6) 2020) THE BLACK INJECTION SCREW OF TWO HUMAPEN ERGO II DID NOT MOVE, SOMETIMES THE INJECTION BUTTON COULD NOT BE PRESSED DOWN AND SOMETIMES THE INJECTION BUTTON COULD ONLY BE PRESSED DOWN A LITTLE AND INSULIN COULD NOT BE EJECTED OUT (PRODUCT COMPLAINTS (B)(4) AND (B)(4)/LOT NUMBERS UNKNOWN). ON (B)(6) 2020, UNKNOWN DATE AFTER COMMENCING INSULIN LISPRO +INSULIN LISPRO NPL TREATMENT AND UNKNOWN TIME AFTER STARTING DE HUMAPEN ERGO II DEVICES, BECAUSE OF THE MALFUNCTION OF THE HUMAPEN ERGO II, THE PATIENT DID NOT INJECT INSULIN LISPRO +INSULIN LISPRO NPL SO FAR (AS REPORTED) AND WAS HOSPITALIZED AND CONVALESCING. FURTHER INFORMATION WAS NOT PROVIDED. INSULIN LISPRO +INSULIN LISPRO NPL WAS DISCONTINUED ON 19OCT2010 AND IT WAS UNKNOWN IF IT WAS RE-ADMINISTERED. INFORMATION REGARDING CORRECTIVE TREATMENT, LABORATORIAL EXAMS AND OUTCOME OF EVENTS WAS NOT PROVIDED. IT WAS UNKNOWN IF PATIENT WAS DISCHARGED FROM HOSPITAL. NO ADDITIONAL FOLLOW-UP WILL BE ATTEMPTED AS REPORTER DECLINED TO BE CONTACTED BY THE COMPANY. THE PATIENT WAS THE OPERATOR OF THE DEVICES AND WAS UNKNOWN IF SHE WAS TRAINED. THE DEVICE MODEL HAD BEEN USED FOR MANY YEARS AND THE REPORTED DEVICES HAD BEEN USED FOR AN UNKNOWN PERIOD. THE SUSPECT HUMAPEN ERGO II DEVICES ASSOCIATED WITH PRODUCT COMPLAINTS (B)(4) AND (B)(4) WERE NOT RETURNED TO THE MANUFACTURER. THE REPORTING CONSUMER DID NOT KNOW IF THE EVENTS WERE RELATED TO INSULIN LISPRO +INSULIN LISPRO NPL TREATMENT. UPDATE 27OCT2020: ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT PERSONNEL ON 22OCT2020 WAS PROCESSED WITHIN INITIAL CASE ENTRY. EDIT 28OCT2020: UPON INTERNAL REVIEW IT WAS DETERMINED DRUG CODING WAS INCORRECT FOR CONCOMITANT HUMAN INSULIN. CASE WAS AMENDED AS NECESSARY, NO OTHER ALTERATIONS WERE MADE TO CASE. EDIT 29OCT2020: UPDATED MEDWATCH FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED. UPDATE 06NOV2020: ADDITIONAL INFORMATION RECEIVED ON 05NOV2020 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. ENTERED DEVICE SPECIFIC SAFETY SUMMARIES (DSSS). UPDATED THE MEDWATCH FIELDS WITH DEVICE INFORMATION AND THE EUROPEAN AND (B)(6) (EU/(B)(6)) DEVICE INFORMATION FOR THE SUSPECT HUMAPEN ERGO II DEVICES ASSOCIATED WITH PRODUCT COMPLAINTS (B)(4) AND (B)(4), WHICH WERE NOT RETURNED TO THE MANUFACTURER. CORRESPONDING FIELDS AND NARRATIVE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285089 HUMAPEN ERGO II FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9557

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization