BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN3

    MDR report key: 1040228 · Received May 8, 2008

    Report

    Report Number
    9681821-2008-00028
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    April 11, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTC PRODUCT = YES.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). NURSE TRIED TO FORCE THE PISTON OF THE NOVOPEN 3 BACK AND IT GOT LOCKED [DEVICE FAILURE]. A NURSE INJECTED A WHOLE NOVORAPID PENFILL [INCORRECT DOSE ADMINISTERED]. CASE DESCRIPTION: MEDICAL DEVICE INFO: NOVOPEN 3 CLASS IIB: THIS SPONTANEOUS CASE FROM FOREIGN COUNTRY WAS REPORTED BY A NOVO NORDSIK SALES REP AS "THE PT'S NURSE DID NOT KNOW HOW TO HANDLE NOVOPEN 3 AND INJECTED A WHOLE NOVORAPID PENFILL. THE NURSES TRIED TO FORCE THE PISTON OF THE NOVOPEN 3 BACK AND IT GET LOCKED" IT CONCERNS A MALE PT TREATED NOVOPEN 3 AND NOVORAPID PENFILL AN UNK DATE DUE TO DIABETES. MEDICAL HISTORY INCLUDES A DISEASE AND MENINGITIS. ON AN UNK DATE THE PT'S NURSE MISTAKENLY INJECTED A WHOLE NOVORAPID PENFILL. THE PT WAS HOSPITALIZED. REPORTER'S CAUSALITY ASSESSMENT: POSSIBLE. NOVO NORDISK CAUSALITY ASSESSMENT: REPORTABLE. ANALYSIS RESULT: PROD: NOVOPEN 3. LOT # SSCB520. DEVICE CONCLUSION: VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE PISTON ROD WAS LOCKED IN ITS OUTER POSITION. IT IS IMPOSSIBLE TO OPERATE THE PEN. THE MOVEMENT ACCURACY OF THE PISTON ROD WAS NOT MEASURED DUE TO THE ABOVE FAULT. PROD NOVORAPID PENFILL - 100UI/ML - 3ML. LOT# TW50273. DRUG CONCLUSION: DUE TO INSUFFICIENT COMPLAINT SAMPLE MATERIAL A REFERENCE SAMPLE CHECK WAS PERFORMED. A REFERENCE SAMPLE WAS EXAMINED MACROSCOPICALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY, DEGRADATION, AND INSULIN ASPART RELATED IMPURITIES WERE EXAMINED. THE REFERENCE SAMPLE WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN3 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S MEDICAL SYSTEMS NA SSCB520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization