BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOPEN ECHO PLUS

    MDR report key: 19133429 · Received April 18, 2024

    Report

    Report Number
    9681821-2024-00069
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Report Date
    March 28, 2024
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMF
    PMA / PMN Number
    K123766N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS NON-SERIOUS SPONTANEOUS CASE FROM SPAIN WAS REPORTED BY A CONSUMER AS "PEAKS OF HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL)(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 9 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO PLUS (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", ON UNSPECIFIED DATE PATIENT HAD A PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL) AND PATIENT HAD HYPERGLYCEMIA. ON (B)(6) 2024, THE CASE WAS DOWNGRADED FROM SERIOUS TO NON-SERIOUS AS IT WAS CONFIRMED THAT PATIENT WAS NOT HOSPITALIZED. SINCE LAST SUBMISSION THE CASE HAVE BEEN UPDATED WITH THE FOLLOWING: SERIOUSNESS CRITERIA UNCHECKED. GXP COMMENT ADDED. NARRATIVE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    EVENT [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) PEAKS OF HYPERGLYCEMIA [HYPERGLYCAEMIA] PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL) [DEVICE FAILURE] CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM SPAIN WAS REPORTED BY A CONSUMER AS "PEAKS OF HYPERGLYCEMIA(HYPERGLYCEMIA)" WITH AN UNSPECIFIED ONSET DATE, "PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL)(DEVICE FAILURE)" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 9 YEARS OLD FEMALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO PLUS (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE FOR "DEVICE THERAPY", PATIENTS HEIGHT, WEIGHT AND BODY MASS INDEX WERE NOT REPORTED. DOSAGE REGIMENS: NOVOPEN ECHO PLUS: MEDICAL HISTORY WAS NOT PROVIDED. ON UNSPECIFIED DATE PATIENT HAD A PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL) AND HAD TO GO TO THE HOSPITAL FOR PEAKS OF HYPERGLYCEMIA. BATCH NUMBERS: NOVOPEN ECHO PLUS: NVGCK37 ACTION TAKEN TO NOVOPEN ECHO PLUS WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PEAKS OF HYPERGLYCEMIA(HYPERGLYCEMIA)" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "PROBLEM WITH NOVOPEN ECHO PLUS (IT DID NOT ADMINISTER INSULIN WELL)(DEVICE FAILURE)" WAS NOT REPORTED. THE EVENT ONSET DATE IS NOT REPORTED IN THE CASE. HOWEVER, THE INCIDENT DATES ARE CAPTURED TO ENSURE THE MIR FORM IS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423633 NOVOPEN ECHO PLUS INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S N/A NVGCK37

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Hospitalization