BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 1031290 · Received April 18, 2008

    Report

    Report Number
    9681821-2008-00022
    Event Type
    Injury
    Date Received
    April 18, 2008
    Report Date
    March 19, 2008
    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
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF THE NOVOPEN 3 [DEVICE MALFUNCTION]. CASE DESCRIPTION: MEDICAL DEVICE INFORMATION: CLASS IIB. THIS SPONTANEOUS CASE FROM FOREIGN COUNTRY WAS REPORTED BY A PHARMACIST AS "MALFUNCTION OF THE NOVOPEN 3" AND CONCERNS A FEMALE PATIENT TREATED WITH/USING NOVOPEN 3 SILVER AND NOVOPEN 3 FOREST GREEN FROM AN UNKNOWN DATE, AND MIXTARD 30 PENFILL (DUAL ACTING HUMAN INSULIN) FROM AN UNKNOWN DATE FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE THIS FEMALE PATIENT WAS HOSPITALISED DUE TO MALFUNCTION OF THE NOVOPEN 3. THE PATIENT IS FURTHERMORE USING MIXTARD 30 AND NOVOFINE NEEDLES. BOTH NOVOPENS HAVE BEEN RETURNED FOR EVALUATION. ONE OF THE SUSPECTED DEVICES EXPIRED IN 1993. NO DATE OF OUTCOME WAS REPORTED AND THE OUTCOME WAS REPORTED AS UNKNOWN. REPORTER'S CAUSALITY ASSESSMENT: POSSIBLE. NOVO NORDISK'S CAUSALITY: REPORTABLE. COMMENT: REPORTER'S ALTERNATIVE ETIOLOGY: NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA 931805

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization