BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN JUNIOR

    MDR report key: 3767462 · Received April 15, 2014

    Report

    Report Number
    9681821-2014-00015
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 14, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    KZH
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS) PUSH BUTTON WILL NOT DEPRESS [DEVICE MALFUNCTION] ([BLOOD GLUCOSE INCREASED]). CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH TREAT? NO. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A MOTHER AND A FRIEND OF THE MOTHER'S. AS "PUSH BUTTON WILL NOT DEPRESS" AND "HIGH BLOOD SUGAR" BEGINNING ON (B)(6) 2014, AND CONCERNED A (B)(6) OLD MALE PT USING NOVOPEN JUNIOR (INSULIN DELIVERY DEVICE) FROM (B)(6) 2013 TO ONGOING, DUE TO TYPE 1 DIABETES MELLITUS. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS DIAGNOSED ON (B)(6) 2013. THE PT HAD NO OTHER MEDICAL CONDITIONS. A MOTHER REPORTED THAT HER SON WAS BEING TREATED WITH NOVOLOG PENFILL SLIDING SCALE, WITH NOVOPEN JUNIOR, FROM (B)(6) 2013. ON (B)(6) 2014, THE PUSH BUTTON WOULD NOT DEPRESS ON THE NOVOPEN JUNIOR, AND AS A RESULT, THE PT WAS HOSPITALIZED WITH HIGH BLOOD SUGAR THAT SAME DAY. THE PT HAD BLOOD SUGAR READINGS ON THE 400'S MD/DL AND 500'S MG/DL. THE PT WAS TREATED WITH NOVOLOG IN THE HOSPITAL. LATER THAT DAY ON (B)(6) 2014, THE PT RECOVERED AND WAS DISCHARGED HOME FROM THE HOSPITAL. ACTION TAKEN TO NOVOPEN JUNIOR WAS REPORTED AS NO CHANGE. THE OUTCOME FOR THE EVENTS WAS REPORTED AS RECOVERED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230834 NOVOPEN JUNIOR INSULIN DELIVER DEVICE KZH NOVO NORDISK A/S NA NV403189

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization NOVOLOG PENFILL (INSULIN ASPART) SOLUTION| LANTUS (INSULIN GLARGINE)| FOR INJECTION, 100 U/ML (B)(6) 2013 TO ONGOING