BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 4

    MDR report key: 3834454 · Received May 9, 2014

    Report

    Report Number
    9681821-2014-00020
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    March 14, 2014
    Manufacturer
    NOVO NORDISK A/S
    Product Code
    FMI
    PMA / PMN Number
    20-986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: NOVOPEN 4 - BATCH: YUG1323. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE PEN WAS RECEIVED WITH A PENFILL MOUNTED. UPON RECEIPT THE PENFILL WAS UNDER PRESSURE INDICATING AN ATTEMPT TO DOSE WITHOUT A NEEDLE MOUNTED OR WITH A CLOGGED NEEDLE MOUNTED. HOWEVER, AFTER MOUNTING A NEW NEEDLE THE PRESSURE WAS RELEASED AND THE DEVICE FUNCTIONED NORMALLY. USE A NEW NEEDLE FOR EACH INJECTION. THE NEEDLE SHOULD BE MOUNTED IMMEDIATELY BEFORE THE INJECTION. ALWAYS REMOVE THE USED NEEDLE IMMEDIATELY AFTER EACH INJECTION AND STORE THE DEVICE WITHOUT A NEEDLE ATTACHED. OTHERWISE, TEMPERATURE FLUCTUATIONS MAY CAUSE LEAKAGE THROUGH THE NEEDLE, RESULTING IN A SPACE BETWEEN THE RUBBER PISTON IN THE CARTRIDGE AND THE PISTON ROD IN THE DEVICE. FURTHERMORE, CLOGGING OF THE NEEDLE MAY OCCUR. FINALLY, PRIMING TO EXPEL AIR MUST ALWAYS BE PERFORMED BEFORE EACH INJECTION, AS STATED IN THE PACKAGE LEAFLET. DURING EXAMINATION AND TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. NOVOMIX 30 - BATCH: CT60225. THE SAMPLE WAS EXAMINED VISUALLY. A LARGE AMOUNT OF AIR WAS PRESENT IN THE CARTRIDGE. IF THE NEEDLE IS NOT REMOVED BETWEEN INJECTIONS INSULIN MAY SEEP OUT AND AIR MAY ENTER THE CARTRIDGE. THE AIR MAY CAUSE MORE OR LESS ACTIVE INSULIN BEING INJECTED, AND THEREBY POTENTIALLY LEAD TO UNCONTROLLED GLYCAEMIA. THE OBSERVED PROBLEM IS DUE TO INCORRECT HANDLING OF THE PRODUCT. ALL CARTRIDGES ARE INSPECTED FOR AIR AT THE CVT INSPECTIONS MACHINE AND THEREFORE, IT IS UNLIKELY THAT THE CARTRIDGE HAS LEFT IN WITH TOO MUCH AIR INSIDE. MICROSCOPICAL EXAMINATIONS WERE PERFORMED AND A TEST FOR BLOOD WAS PERFORMED. NO BLOOD WAS DETECTED. ON (B)(6) 2014: THE EVENT "AIRBUBBLES AND BLOOD IN CARTRIDGE DURING INJECTION" DOES NOT FULFIL THE DEFINITION OF AN ADVERSE EVENT NOR MEDICAL DEVICE INCIDENT, BUT A TECHNICAL COMPLAINT, THEREFORE, THE CASE IS CAPTURED AS TECHNICAL COMPLAINT (TC) IN NOVO NORDISK COMPLAINT HANDLING SYSTEM. THE CASE NO LONGER QUALIFIES FOR EXPEDITED REPORTING. REPORTER COMMENT: CAUSALITY WAS REPORTED AS POSSIBLE. ACCORDING TO PHARMACIST THIS PROBLEM WAS SERIOUS AND MEDICALLY SIGNIFICANT. NOVOPEN 4 BLUE - BATCH YUG1323. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE PEN WAS RECEIVED WITH A PENFILL MOUNTED. UPON RECEIPT THE PENFILL WAS UNDER PRESSURE INDICATING AN ATTEMPT TO DOSE WITHOUT A NEEDLE MOUNTED OR WITH A CLOGGED NEEDLE MOUNTED. HOWEVER, AFTER MOUNTING A NEW NEEDLE THE PRESSURE WAS RELEASED AND THE DEVICE FUNCTIONED NORMALLY. USE A NEW NEEDLE FOR EACH INJECTION. THE NEEDLE SHOULD BE MOUNTED IMMEDIATELY BEFORE THE INJECTION. ALWAYS REMOVE THE USED NEEDLE IMMEDIATELY AFTER EACH INJECTION AND STORE THE DEVICE WITHOUT A NEEDLE ATTACHED. OTHERWISE TEMPERATURE FLUCTUATIONS MAY CAUSE LEAKAGE THROUGH THE NEEDLE, RESULTING IN A SPACE BETWEEN THE RUBBER PISTON IN THE CARTRIDGE AND THE PISTON ROD IN THE DEVICE. FURTHERMORE, CLOGGING OF THE NEEDLE MAY OCCUR. FINALLY, PRIMING TO EXPEL AIR MUST ALWAYS BE PERFORMED BEFORE EACH INJECTION, AS STATED IN THE PACKAGE LEAFLET. DURING EXAMINATION AND TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    AIRBUBBLES AND BLOOD IN CARTRIDGE DURING INJECTION [PRODUCT CONTAMINATION WITH BODY FLUID]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH THREAT? NO. THIS SERIOUS SPONTANEOUS CASE REPORTED BY A PHARMACIST FROM (B)(6), AND CONCERNS A FEMALE PT (AGE: NOT REPORTED) WHO USED NOVOPEN 4 (INSULIN DELIVERY DEVICE, FOR DEVICE THERAPY) WITH NOVOMIX 30 (DUAL ACTING INSULIN ASPART) FOR AN UNK INDICATION AND REPORTED "AIRBUBBLES AND BLOOD IN CARTRIDGE DURING INJECTION" BEGINNING ON (B)(6) 2011 AND ONGOING. PT HEIGHT NOT REPORTED. MEDICAL HISTORY WAS NOT REPORTED. THE PT REPORTED THAT ON UNK DATES SOMETIMES AFTER INJECTING NOVOMIX 30 AIRBUBBLES WERE PRESENT IN THE CARTRIDGE AND SOMETIMES WHEN THE PT WAS INJECTING, BLOOD CAME INTO THE NEEDLE. A FUNCTION TEST WAS NOT PERFORMED FOR NOVOPEN 4. THE PT USED THE SAME NEEDLE FOR 2 INJECTIONS FOR HIS DOSE IN THE MORNING AND IN THE EVENING. THE PT DID NOT HAVE THIS PROBLEM WITH THE NEW NOVOPEN 4. ACTION TAKEN TO NOVOMIX 30 WAS REPORTED AS NO CHANGE. THE OVERALL OF EVENT WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281084 NOVOPEN 4 INSULIN DELIVERY DEVICE FMI NOVO NORDISK A/S NA YUG1323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NOVOMIX 30 (INSULIN ASPART) SUSPENSION FOR| INJECTION, 100U/ML, LOT # CT60225