BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN ECHO

    MDR report key: 13860542 · Received March 23, 2022

    Report

    Report Number
    9681821-2022-00025
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    February 14, 2022
    Report Date
    February 24, 2022
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K123766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). HIGH BLOOD SUGAR OF 506 MG/DL [BLOOD GLUCOSE INCREASED]. NOVOPEN ECHO DID NOT DISPENSE THE MEDICATION [DEVICE FAILURE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A CONSUMER AS "HIGH BLOOD SUGAR OF 506 MG/DL(BLOOD SUGAR INCREASED)" BEGINNING ON (B)(6) 2022, "NOVOPEN ECHO DID NOT DISPENSE THE MEDICATION(DEVICE FAILURE)" BEGINNING ON (B)(6) 2022, AND CONCERNED A (B)(6) YEAR OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS", NOVOLOG PENFILL (INSULIN ASPART) (DOSE, FREQUENCY & ROUTE USED-UNK, SUBCUTANEOUS) FROM UNKNOWN START DATE FOR "DIABETES MELLITUS". CURRENT CONDITION: DIABETES MELLITUS (TYPE AND DURATION NOT REPORTED). CONCOMITANT PRODUCTS INCLUDED - LANTUS(INSULIN GLARGINE). TREATMENT INCLUDED - NOVOLOG(INSULIN ASPART) . ON (B)(6) 2022 , PATIENT'S NOVOPEN ECHO DID NOT DISPENSE THE MEDICATION AND AS A RESULT THE PATIENT HAD A BLOOD SUGAR OF 506 MG/DL. PATIENT TREATED WITH NOVOLOG VIAL THAT THE HCP PRESCRIBED AS TREATMENT AND PATIENT RECOVERED THE SAME DAY. ON AN UNSPECIFIED DATE IN (B)(6) 2022, THE PATIENT'S BLOOD SUGAR WAS 225 MG/DL. BATCH NUMBER WAS REQUESTED. ACTION TAKEN TO NOVOPEN ECHO WAS NOT REPORTED. ACTION TAKEN TO NOVOLOG PENFILL WAS NOT REPORTED. ON (B)(6) 2022 THE OUTCOME FOR THE EVENT "HIGH BLOOD SUGAR OF 506 MG/DL(BLOOD SUGAR INCREASED)" WAS RECOVERED. THE OUTCOME FOR THE EVENT "NOVOPEN ECHO DID NOT DISPENSE THE MEDICATION(DEVICE FAILURE)" WAS NOT RECOVERED. ON (B)(6) 2022 IT WAS IDENTIFIED THAT IRD WAS CAPTURED INCORRECTLY. IRD SHOULD BE (B)(6) 2022 AND NOT (B)(6) 2022 . THE CASE WAS INITIALLY REPORTED AS TC ONLY ON (B)(6) 2022 . ON (B)(6) 2022 , SERIOUS ADVERSE EVENT RELATED TO THE TC WAS REPORTED . HENCE THE CASE CORRECTION HAS BEEN PERFORMED AND AMR WAS FILED.

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULT: NOVOPEN ECHO - BATCH UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT FOR FURTHER INVESTIGATIONS. NOVOLOG® PENFILL® 3 ML CARTRIDGES 100 UNITS/ML (U-100) - BATCH UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT(S) FOR FURTHER INVESTIGATIONS. SINCE LAST SUBMISSION THE CASE HAS BEEN UPDATED WITH THE FOLLOWING: -INVESTIGATION RESULT UPDATED. -IMDRF ANNEX B, C, D, G CODES UPDATED. -NARRATIVE UPDATED ACCORDINGLY. FINAL MANUFACTURER'S COMMENT: 21-APR-2022: THE SUSPECTED DEVICE (NOVOPEN ECHO) HAS NOT BEEN RETURNED TO NOVO NORDISK A/S FOR THE INVESTIGATION. BATCH NUMBER OF DEVICE IS NOT AVAILABLE IN SPITE OF REPEATED EFFORTS TO GET THE SAME. BATCH TREND ANALYSIS OR REFERENCE SAMPLE ANALYSIS WERE NOT PERFORMED. WITH THE AVAILABLE LIMITED INFORMATION REGARDING THE HANDLING OF THE SUSPECTED DEVICE, IT IS NOT POSSIBLE TO IDENTIFY A CLEAR ROOT CAUSE IN RELATION TO FUNCTIONALITY OF NOVOPEN ECHO. PATIENT'S UNDERLYING MEDICAL CONDITION OF DIABETES MELLITUS AND ELDERLY AGE ARE RISK FACTORS FOR THE DEVELOPMENT OF HYPERGLYCAEMIA. H3 CONTINUED: EVALUATION SUMMARY: NOVOPEN ECHO - BATCH UNKNOWN. NO INVESTIGATION WAS POSSIBLE, BECAUSE NEITHER SAMPLE NOR BATCH NUMBER WAS AVAILABLE. IF POSSIBLE, PLEASE FORWARD THE REPORTED PRODUCT FOR FURTHER INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE DESCRIPTION: ON (B)(6) 2022, IT WAS IDENTIFIED THAT IRD WAS CAPTURED INCORRECTLY. IRD SHOULD BE (B)(6) 2022 AND NOT (B)(6) 2022. THE CASE WAS INITIALLY REPORTED AS TC ONLY ON (B)(6) 2022. ON (B)(6) 2022, SERIOUS ADVERSE EVENT RELATED TO THE TC WAS REPORTED . HENCE AN AMENDMENT WAS PERFORMED AND AMR WAS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768859 NOVOPEN ECHO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other LANTUS (INSULIN GLARGINE).