BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3 (INSULIN DELIVERY DEVICE) NA

    MDR report key: 1764291 · Received July 16, 2010

    Report

    Report Number
    9681821-2010-00027
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    October 24, 2009
    Report Date
    June 18, 2010
    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

    PT WAS NOT WELL [MALAISE]. A BROKEN NOVORAPID PENFILL IN HER NOVOPEN 3 [DEVICE BREAKAGE]. ([BLOOD GLUCOSE INCREASED]). KETONES ++4 [BLOOD KETONE BODY]. CASE DESCRIPTION: THE INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. MEDICAL DEVICE INFO: CLASS LLB. THIS SPONTANEOUS CASE FROM THE NETHERLANDS WAS REPORTED BY A PHARMACIST AS "BROKEN NOVORAPID PENFILL IN HER NOVOPEN 3", "BLOOD GLUCOSE 29.3", "KETONES ++4" AND "PT WAS NOT WELL" AND CONCERNS A (B)(6) FEMALE PT TREATED WITH NOVOPEN 3 AND NOVORAPID PENFILL (FAST-ACTING INSULIN ASPART) FROM AN UNK DATE TO AN UNK DATE FOR TYPE 1 DIABETES MELLITUS. PT'S HEIGHT: NOT REPORTED. PT'S MEDICAL HISTORY INCLUDES DOWN'S SYNDROME AND THYROID DISORDER. IN SEPT-2009, IT WAS REPORTED THAT THE PT WAS ADMITTED TO HOSPITAL DUE TO A BROKEN NOVORAPID PENFILL IN HER NOVOPEN 3. FOLLOW-UP INFO INFERRED THAT THIS EVENT OCCURRED IN (B)(6) 2009. ON (B)(6)-2009, THE PT WENT TO HOSPITAL DUE TO BLOOD GLUCOSE LEVEL 29.3 AND KETONES ++4. AFTER TREATMENT, THE PT WAS DISCHARGED TO HER HOME. ON (B)(6)-2009 TO (B)(6)-2009, THE PT WAS ADMITTED TO HOSPITAL AGAIN AS THE PT WASN'T WELL. THE PT'S MOTHER DISCOVERED THAT BOTH DELIVERY SYSTEMS FOR NOVORAPID AND LEVEMIR (INSULIN DETEMIR) WEREN'T FUNCTIONING PROPERLY. IT WAS REPORTED THAT THE DELIVERY SYSTEMS WERE DISPOSED OF. THE PENS, WHICH WERE RETURNED TO NOVO NORDISK, ARE RELEVANT FOR THE EVENTS TAKING PLACE IN (B)(6)-2010 NOT THE EVENTS IN PRESENT CASE. OUTCOME FOR "BLOOD GLUCOSE 29.3", "KETONES ++4" AND "PT WAS NOT WELL" WAS RECOVERED AND OUTCOME FOR "BROKEN NOVORAPID PENFILL IN HER NOVOPEN 3" WAS NOT REPORTED. THIS CASE (B)(4) (REGARDING EVENTS TAKING PLACE IN (B)(6)-2010). COMPANY COMMENT: TWO OTHER CASE WITH SIMILAR ROOT CAUSE AS CASE (B)(4) HAS BEEN REPORTED. IN BOTH CASES ROUGH HANDLING OF THE PEN AND PENFILLS WAS THE CAUSE OF THE CRACKED PENFILL. ON BASIS OF LIMITED NUMBER OF CASES WITH SIMILAR ROOT CAUSE NOVO NORDISK A/S DOES NOT SEE THIS AS A SAFETY CONCERN. RPTR COMMENT: RPTR'S ALTERNATIVE AETIOLOGY: NOT REPORTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization