BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA

    MDR report key: 1982258 · Received January 31, 2011

    Report

    Report Number
    9681821-2011-00005
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    October 3, 2004
    Report Date
    January 3, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER COMMENT: MANUFACTURERS COMMENT: AS NO DEVICE HAS BEEN RETURNED, TO NOVO NORDISK (B)(4) FOR INVESTIGATION, IT IS NOT POSSIBLE TO FIND A CLEAR ROOT-CAUSE FOR EXPERIENCED EVENTS. A REVIEW OF THE BATCH DOCUMENTATION REGARDING BATCH HSC1945 DID NOT REVEAL ANYTHING UNUSUAL. AN NO CLEAR ROOT CAUSE HAS BEEN IDENTIFIED, NO CORRECTIVE ACTION HAS BEEN INITIATED. HOWEVER, THE REPORTING RATE FOR HYPOGLYCAEMIC RELATED EVENTS SEEN IN CONNECTION TO NOVOPEN 3 USE IS LOW AND STABLE.

    Description of Event or Problem · 1

    NON CALIBRATION OF THE PEN [DEVICE MALFUNCTION]. HYPOGLYCAEMIC CRISIS AND WAS UNCONSCIOUS [HYPOGLYCAEMIC UNCONSCIOUSNESS]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS IIB. THIS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY REPORTER AS "NON CALIBRATION OF THE PEN" AND "HYPOGLYCAEMIC CRISIS AND WAS UNCONSCIOUS" AND CONCERNS A (B)(6) MALE PT USING NOVOPEN 3 SINCE 2000 OR 2001 TO AN UNK DATE DUE TO TYPE 2 DIABETES MELLITUS. (B)(6). MEDICAL HISTORY WAS NOT REPORTED. THE PT SUSPECTS THAT DUE TO NON CALIBRATION OF HIS PEN, ON (B)(6) 2004, HE HAD A HYPOGLYCAEMIA CRISIS AND WAS UNCONSCIOUS FOR 20 MINUTES. THE PT WAS HOSPITALIZED FOR 3 DAYS. THE PEN WAS NOT CALIBRATED WHEN HE SELECTED A HIGHER DOSAGE, AND WHEN HE TRIED TO DECREASE TO ZERO. HE SEPARATED THE MECHANISM AND PUSHED TO ZERO AND THE SELECTOR RETURNED TO THE INITIAL POSITION. THEN, WHEN HE PRESSED AGAIN UP TO ZERO, A FLOW OF INSULIN CAME OUT OF THE PEN. THE PT USED NOVOFINE 6 MM NEEDLES. EACH NEEDLE WAS USED FOR 1 WHOLE WEEK (14 INJECTIONS) AND WAS LEFT ATTACHED TO THE PEN IN-BETWEEN INJECTIONS. DURING USE OF THE PEN, IT WAS KEPT OUTSIDE OF THE REFRIGERATOR. THE INSULIN NOT IN USE WAS KEPT IN THE REFRIGERATOR. THE PEN WAS BOUGHT IN 2001 AND USED WHEN HE TRAVELS, "AS THE PUBLIC SYSTEM GIVES HIM PENFILL PRESENTATION". BY THE TIME HE BOUGHT THE PEN, HE USED IT FREQUENTLY. HOWEVER, AFTER HE STARTED RECEIVING MEDICINE FROM THE PUBLIC SYSTEM, HE STARTED TO MAKE INJECTIONS WITH SYRINGE. THE USE OF THE SPECIFIC NOVOPEN 3 WAS DISCONTINUED ON AN UNK DATE. ON (B)(6) 2004, THE PT RECOVERED FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA HSC1945

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization NOVOLIN N PENFILL (INSULIN HUMAN) SUSPENSION FOR| NOVOFINE 6 MM (NEEDLE) NA| INJECTION, 100 IU/ML