BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE, UNSPECIFIED

    MDR report key: 8960867 · Received September 4, 2019

    Report

    Report Number
    9681821-2019-00059
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    August 6, 2019
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SERIOUS SOLICITED REPORT FROM CANADA WAS REPORTED BY A CONSUMER LATER CONFIRMED BY HEALTH CARE PROFESSIONAL AS "PSORIASIS LIKE LESIONS" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A 62 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NEEDLE, UNSPECIFIED (NEEDLE) FROM UNKNOWN START DATE DUE TO "DIABETES MELLITUS", NOVORAPID (INSULIN ASPART) FROM (B)(6) 2019 AND ONGOING , DUE TO "DIABETES MELLITUS" (REGIMEN #1 DOSE AND FREQUENCY UNKNOWN, REGIMEN #2 DOSE AND FREQUENCY 117 IU). A NON-NOVO NORDISK SUSPECT PRODUCT TOUJEO (INSULIN GLARGINE) FROM (B)(6) 2018 AND ONGOING DUE TO "DIABETES MELLITUS" (REGIMEN #1 DOSE AND FREQUENCY UNKNOWN, REGIMEN #2 DOSE AND FREQUENCY 75 IU). ACTION TAKEN TO NEEDLE, UNSPECIFIED WAS PRODUCT DISCONTINUED. ACTION TAKEN TO NOVORAPID WAS REPORTED AS DOSE INCREASED. ACTION TAKEN TO TOUJEO WAS REPORTED AS NO CHANGE. REPORTER'S CAUSALITY ( NOVORAPID) - PSORIASIS LIKE LESIONS : UNLIKELY. COMPANY'S CAUSALITY ( NOVORAPID) - PSORIASIS LIKE LESIONS : UNLIKELY. INVESTIGATION RESULT:: NEEDLES 6 MM- BATCH UNKNOWN: NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. SINCE LAST SUBMISSION FOLLOWING HAS BEEN UPDATED: -MEDICAL CONFIRMATION UPDATED -REPORTER GOT UPDATED -NOVORAPID AND TOUJEO WERE UPGRADED TO SUSPECT -REPORTER CAUSALITY UPDATED -EVENT ASSESSMENT GOT UPDATED -OPERATOR OF DEVICE UPDATED -OTHER RELEVANT HISTORY UPDATED -INVESTIGATION RESULTS ADDED -MANUFACTURER COMMENT UPDATED -NARRATIVE UPDATED ACCORDINGLY -REPORTER COMMENT UPDATED. MANUFACTURER COMMENT: 16-SEP-2019: AS THE DEVICE (NEEDLES 6 MM) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR INVESTIGATION AND ONLY VERY LIMITED INFORMATION REGARDING THE HANDLING OF SUSPECTED DEVICE IS AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT-CAUSE OF THE EXPERIENCED ADVERSE EVENT AND THUS FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS CASE (B)(4). REPORTER COMMENT: PATIENT REPORTED HIS FAMILY DOCTOR PROVIDED HIM WITH 6 MM NEEDLES THAT HE REPORTS WAS THE CAUSE OF HIS LESIONS. HCP THINKS THAT EVENT IS LIKELY RELATED TO 6 MM NEEDLES INSTEAD AS PT REPORTS 4 MM NEEDLE GIVE HIM NO ISSUES. PATIENT DENIES REUSING NEEDLES. HCP NOT SURE IF PATIENT HAS BEEN TRAINED TO USE THE NEEDLE IN QUESTION, ALSO REPORTED THAT PATIENT DOES LEAVE NEEDLE ATTACHED TO PEN IN BETWEEN INJECTION, PT DID ENSURE THAT NEEDLE WAS PROPERLY ATTACHED TO PEN, NEEDLE IS ATTACHED TO THE PEN AT 180 DEGREE ANGLE. H3 CONTINUED: EVALUATION SUMMARY NEEDLES 6 MM- BATCH UNKNOWN NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE.

    Description of Event or Problem · 1

    CASE DESCRIPTION: STUDY ID: DIABETES INJECTION ASSISTANCE. STUDY DESCRIPTION: TRIAL TITLE: THE OBJECTIVE OF THE STUDY IS TO ENABLE PATIENTS WHO REQUIRE INITIATION OR INTENSIFICATION OF INJECTABLE DIABETES THERAPY TO RECEIVE THE PROPER TRAINING IN A TIMELY FASHION VIA THE PROVISION OF A DIABETES EDUCATOR. THIS SERIOUS SOLICITED REPORT FROM (B)(6) WAS REPORTED BY A CONSUMER AS "PSORIASIS LIKE LESIONS" WITH AN UNSPECIFIED ONSET DATE AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH NEEDLE, UNSPECIFIED (NEEDLE) FROM UNKNOWN START DATE DUE TO "DIABETES MELLITUS." PATIENT HEIGHT, WEIGHT AND BMI NOT REPORTED. MEDICAL HISTORY INCLUDED DIABETES MELLITUS SINCE 1999 (TYPE: NOT REPORTED). CONCOMITANT MEDICATIONS INCLUDED - NOVORAPID(INSULIN ASPART) SOLUTION FOR INJECTION, 100 U/ML, TOUJEO(INSULIN GLARGINE). TREATMENT MEDICATIONS INCLUDED - HYDROCORTISONE(HYDROCORTISONE). IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PSORIASIS LIKE LESIONS ON LOWER BILATERAL QUADRANTS OF ABDOMEN FOR THE PAST YEAR. IT WAS ALSO REPORTED THAT PSORIASIS LIKE LESIONS COINCIDES WITH TAKING FOURS INJECTIONS PER DAY AND NEEDLE WAS THE CAUSE OF EVENT. FAMILY DOCTOR GAVE PATIENT HYDROCORTISONE CREAM AS TREATMENT. THE OUTCOME FOR THE EVENT "PSORIASIS LIKE LESIONS" WAS RECOVERING/RESOLVING. ACTION TAKEN TO NEEDLE, UNSPECIFIED WAS PRODUCT DISCONTINUED. BATCH NUMBER OF NEEDLE REQUESTED. REPORTER'S CAUSALITY ( NEEDLE, UNSPECIFIED) - PSORIASIS LIKE LESIONS : POSSIBLE. COMPANY'S CAUSALITY ( NEEDLE, UNSPECIFIED) - PSORIASIS LIKE LESIONS : UNLIKELY. REPORTER COMMENT: PATIENT REPORTED HIS FAMILY DOCTOR PROVIDED HIM WITH 6 MM NEEDLES THAT HE REPORTS WAS THE CAUSE OF HIS LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756836 NEEDLE, UNSPECIFIED NEEDLE FMI NOVO NORDISK A/S N/A UNKNOWN
    756837 TOUJEO (INSULIN GLARGINE) ---
    756838 NOVORAPID ---
    756839 TOUJEO ---

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other NOVORAPID (INSULIN ASPART) (B)(6) 2019 TO ONGOING| NOVORAPID (INSULIN ASPART) (B)(6) 2019 TO UNK| TOUJEO (INSULIN GLARGINE) (B)(6) 2018 TO UNK| TOUJEO (INSULIN GLARGINE) (B)(6) 2019 TO ONGOING