BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A

    MDR report key: 2062652 · Received April 11, 2011

    Report

    Report Number
    9681821-2011-00018
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    19-938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HYPOGLYCAEMIC EPISODE, FUNNY TURN [HYPOGLYCAEMIA]. THE EVENT COULD BE DUE TO THE PEN [PRODUCT QUALITY ISSUE]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFORMATION: CLASS IIB. THIS SPONTANEOUS CASE FROM THE (B)(6) WAS REPORTED BY A CONSUMER AS "HYPOGLYCAEMIC EPISODE, FUNNY TURN" AND "THE EVENT COULD BE DUE TO THE PEN" (NON-SERIOUS). IT CONCERNS A FEMALE PATIENT USING NOVOPEN 3 FROM AN UNKNOWN DATE TO UNKNOWN DATE DUE TO DIABETES MELLITUS. PATIENT'S HEIGHT AND MEDICAL HISTORY WAS NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2011 THE PATIENT PRESENTED WITH A "FUNNY TURN" WHERE SHE WAS ACTING STRANGELY AND WOULD NOT TAKE GLUCOSE OR HAVE HER BLOOD GLUCOSE TESTED. SHE WAS TAKEN TO THE HOSPITAL WHERE SHE WAS DIAGNOSED TO BE HAVING A HYPOGLYCAEMIC EPISODE. SHE WAS NOT ADMITTED BUT IT WAS ADVISED THAT THE EVENT COULD BE DUE TO THE PEN. IT IS UNKNOWN WHETHER THE PATIENT RECEIVED ANY TREATMENT. NOVOFINE 31G/6MM NEEDLE WAS CHANGED AFTER EACH INJECTION, DEVICE NOT STORED WITH THE NEEDLE ATTACHED. OUTCOME OF EVENTS WAS REPORTED AS "UNKNOWN." PLEASE NOTE: THE RECEIPT DATE OF INITIAL INFORMATION FOR THIS CASE IS (B)(4) 2011 NOT (B)(4) 2011. THE DATE CANNOT BE UPDATED DUE TO A SAFETY DATABASE LIMITATION AFTER THE CASE HAS BEEN PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 (INSULIN DELIVERY DEVICE) N/A INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA TUG0016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization NOVOFINE 31G (NEEDLE)| NOVORAPID (INSULIN ASPART) SOLUTION FOR INJECTION| LEVEMIR (INSULIN DETEMIR) SOLUTION FOR INJECTION| 100 U/ML| .0024 MOL/L