BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 1241610 · Received November 20, 2008

    Report

    Report Number
    9681821-2008-00042
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRACTURED HIP [HIP FRACTURE]. INSULIN WAS FROZEN [MEDICATION ERROR] ([DIABETIC KETOACIDOSIS]). CASE DESCRIPTION: MEDICAL DEVICE INFO: CLASS LLB. THIS SPONTANEOUS CASE FROM THE UNITED KINGDOM WAS REPORTED BY A MEDICAL DR AS "PT HOSPITALIZED DUE TO FRACTURED HIP", "INSULIN WAS FROZEN", "BLOOD SUGAR LEVELS ROSE TO OVER 20 AND PT WENT INTO DIABETIC KETOACIDOSIS". IT CONCERNS A MALE PT TREATED WITH LEVEMIR (INSULIN DETEMIR), NOVORAPID (FAST ACTING INSULIN ASPART) AND NOVOPEN 3 FROM AN UNK DATE DUE TO TYPE 1 DIABETES MELLITUS. PT'S HEIGHT: NOT REPORTED. MEDICAL HISTORY INCLUDES CARDIOVASCULAR ACCIDENT AND FRACTURED HIP. THE PT WAS HOSPITALIZED FROM UNK DATE BECAUSE HE HAD FRACTURED HIP. HE HAD BEEN ON INSULIN (NOVORAPID AND LEVEMIR) FOR A WHILE WITH NO PREVIOUS PROBLEMS. WHILST IN HOSP, HIS INSULIN WAS STORED IN HIS NOVOPEN 3 IN THE FRIDGE BUT THESE WERE RESTING AGAINST THE FREEZER PART OF THE FRIDGE. IN 2008 THROUGH THE DAY, HIS BLOOD GLUCOSE LEVEL INCREASED FROM THE NORMAL 6-10 MMOL/L TO 16 MMOL/L. ON THE NEXT DAY AT 08:00, THE BLOOD GLUCOSE LEVEL HAD INCREASED TO 24 MMOL/L. EXTRA NOVORAPID INSULIN WAS GIVEN AT BREAKFAST. PT STILL APPEARED WELL. AT 16:00, THE PT WAS DROWSY, DRY AND HIS BLOOD GLUCOSE LEVEL HAD INCREASED TO 32 MMOL/L. IV INSULIN PUMP COMMENCED. DIABETIC KETOACIDOSIS WAS DIAGNOSED. IT WAS NOTED THAT THE INSULIN AND PEN HAD BEEN RESTING AGAINST THE ICE BOX IN THE FRIDGE AND WAS VERY COLD. THE NURSE SAYS THAT THERE IS A STRONG POSSIBILITY THAT THE INSULIN WAS FROZEN AND HENCE HAD BECOME INACTIVE. THE PT WAS TREATED WITH A NEW BATCH OF INSULIN AND HAS RECOVERED COMPLETELY. THE PT HAS RECOVERED COMPLETELY. ANALYSIS RESULT: PRODUCT: NOVORAPID PENFILL. LOT NO.: VT60531. DRUG CONCLUSION: THE RETURNED PRODUCT WAS EXAMINED MACROSCOPICALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY, DEGRADATION, AND INSULIN ASPART RELATED IMPURITIES WERE EXAMINED. THERE IS NO SIGN THAT THE PRODUCT HAS BEEN DAMAGED BY FROST. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECS. PRODUCT: LEVEMIR PENFILL. LOT NO.: VT60245. DRUG CONCLUSION: THE RETURNED PRODUCT WAS EXAMINED MACROSCOPICALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY, DEGRADATION, AND INSULIN ASPART RELATED IMPURITIES WERE EXAMINED. THERE IS NO SIGN THAT THE PRODUCT HAS BEEN DAMAGED BY FROST. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECS. COMMENT: CO COMMENT - THERE IS ONLY LIMITED INFO PROVIDED REGARDING THE EVENT "FRACTURED HIP". THE MISSING INFO: PT MEDICAL HISTORY, CONCOMITANT DISEASES AND THE CIRCUMSTANCES WHEN EVENT HAD OCCURRED. HOWEVER, THE PT WITH TYPE I DIABETES AND HIP FRACTURE COMMONLY OCCURS IN THIS GROUP OF PTS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R