BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN ECHO

    MDR report key: 7213917 · Received January 23, 2018

    Report

    Report Number
    9681821-2018-00003
    Event Type
    Injury
    Date Received
    January 23, 2018
    Report Date
    January 3, 2018
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K123766
    Removal / Correction Number
    00000-7/3/17-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM SPAIN WAS REPORTED BY A PHARMACIST AS "SEVERE HYPERGLYCAEMIA" WITH AN UNSPECIFIED ONSET DATE, "IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE" WITH AN UNSPECIFIED ONSET DATE, "OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A 9 YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM (B)(6) 2016 DUE TO "TYPE 1 DIABETES MELLITUS. PATIENT'S HEIGHT: 133 CM. PATIENT'S WEIGHT: 27 KG. PATIENT'S BMI: 15.263. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (SINCE (B)(6) 2016). CONCOMITANT PRODUCTS INCLUDED - NOVORAPID PENFILL(INSULIN ASPART) SOLUTION FOR INJECTION, 100 U/ML AT FIRST IT WAS SUSPECTED THAT THE PATIENT WAS SHEDDING A VIRUS BUT FINALLY OPERATOR REALIZED THAT THE PEN PRIMED EACH TIME DIFFERENT DOSES. DURING THREE WEEKS WHEN THE HYPERGLYCAEMIAS HAPPENED, THE PATIENT WAS ADMINISTERED INSULIN EVERY TWO HOURS AND THE PATIENT WAS UNCONTROLLED. ON AN UNKNOWN DATE, DEVICES WERE CHANGED AND THE EVENT WAS ABATED. ACTION TAKEN TO NOVOPEN ECHO WAS DEVICES WERE CHANGED TO NEW ONE. THE OUTCOME FOR THE EVENT "SEVERE HYPERGLYCAEMIA" WAS RECOVERED. THE OUTCOME FOR THE EVENT "IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON" WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE. SINCE LAST SUBMISSION THIS CASE HAS BEEN UPDATED WITH THE FOLLOWING PATIENT'S WEIGHT AND HEIGHT UPDATED DURATION OF DIABETES ADDED. THE OUTCOME FOR THE EVENT SEVERE HYPERGLYCAEMIA WAS CHANGED FROM UNKNOWN TO RECOVERED. START DART DATE OF NOVOPEN ECHO ADDED. BATCH NUMBER OF NOVOPEN ECHO ADDED. CATALOG # OF NOVOPEN ECHO ADDED. MANUFACTURING DATE OF NOVOPEN ECHO ADDED. RECALL FOR NOVOPEN ECHO ADDED. CONCOMITANT MEDICAL PRODUCT ADDED. REPORTER COMMENT UPDATED. NARRATIVE UPDATED. REPORTER COMMENT: THE PATIENT PRESENTED WITH HYPERGLYCAEMIAS DUE TO THE DEVICES WERE DEFECTIVE "IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE", "OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON".

    Description of Event or Problem · 0

    CASE DESCRIPTION: INVESTIGATION RESULT: NAME: NOVOPEN ECHO - BATCH DVG1564-6: THE DEVICE WAS RETURNED WITH THE CARTRIDGE FROM THIS CASE MOUNTED. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE MEMORY DISPLAY SHOWED TWO LINES AND THE ELECTRONIC REGISTER COULD NOT BE REACHED. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. THE MEMORY DISPLAY KEPT SHOWING TWO LINES AFTER EACH DOSAGE. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. THE DEVICE WAS DISASSEMBLED TO EXAMINE INTERNAL PARTS AND A MICROSCOPIC EXAMINATION WAS PERFORMED. CORROSION WAS OBSERVED INSIDE THE PEN ELECTRONICS. CONFIRMED: THE DISPLAY SHOWED TWO LINES INSTEAD OF THE LAST INJECTED DOSE SIZE DUE TO CORROSION OF THE ELECTRONICS. SOME KIND OF LIQUID HAS ENTERED THE PEN. IT IS NOT POSSIBLE TO USE THE DOSE MEMORY FUNCTION. THE MECHANICAL FUNCTION OF THE PEN IS NOT AFFECTED BY THE FAULTY DISPLAY. THE FAULT IS CAUSED BY ACCIDENTAL DAMAGE DURING USE OF THE DEVICE. THE BATCH DOCUMENTATION WAS REVIEWED NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. NAME: NOVOPEN ECHO - BATCH EVG2914-4 THE ELECTRONIC REGISTER WAS CHECKED. NO REMARKS. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED AND THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. THE MEMORY DISPLAY MIRRORED ALL DOSE SIZES SELECTED BY RANDOM CORRECTLY. THE FUNCTION OF THE PUSH BUTTON WAS FOUND TO BE NORMAL. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE PEN HAS BEEN TESTED SYSTEMATICALLY. NO FAULTS WERE FOUND. SCANNING OF INTERNAL PEN PARTS WAS PERFORMED. THERE WERE NO VISIBLE DEFECTS INSIDE THE PEN. IT HAS NOT BEEN POSSIBLE TO FIND ANY DEFECTS IN THIS PEN. DURING ALL TESTS THE DISPLAY SHOW THE CORRECT DOSAGE DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND. SINCE LAST SUBMISSION THIS CASE HAS BEEN UPDATED WITH THE FOLLOWING INVESTIGATION RESULT UPDATED. MANUFACTURER'S COMMENT UPDATED. SUSPECT MEDICAL DEVICE EXPIRATION DATE ADDED. NARRATIVE UPDATED. MANUFACTURER'S COMMENT/COMPANY COMMENT: 26-MAR-2018 :FOR THE RETURNED DEVICE NOVOPEN ECHO - BATCH DVG1564-6 -THE MEMORY DISPLAY SHOWED TWO LINES AND THE ELECTRONIC REGISTER COULD NOT BE REACHED. THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED AND IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. IT WAS CONCLUDED THAT THE DISPLAY SHOWED TWO LINES INSTEAD OF THE LAST INJECTED DOSE SIZE DUE TO CORROSION OF THE ELECTRONICS. SOME KIND OF LIQUID HAS ENTERED THE PEN. IT IS NOT POSSIBLE TO USE THE DOSE MEMORY FUNCTION. THE MECHANICAL FUNCTION OF THE PEN IS NOT AFFECTED BY THE FAULTY DISPLAY. THE FAULT IS CAUSED BY ACCIDENTAL DAMAGE DURING USE OF THE DEVICE. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. ON INVESTIGATION OF THE NOVOPEN ECHO - BATCH EVG2914-4- THE FUNCTION OF THE PUSH BUTTON WAS FOUND TO BE NORMAL AND IT HAS NOT BEEN POSSIBLE TO FIND ANY DEFECTS IN THIS PEN. THE PRODUCT WAS FOUND TO BE NORMAL. HENCE IT IS NOT POSSIBLE TO FIND SIMILAR INCIDENTS TO THE ONE REPORTED IN ARGUS (B)(4). DEVICE EVALUATED BY MFR: EVALUATION SUMMARY: NOVOPEN ECHO - BATCH EVG2914-4. THE ELECTRONIC REGISTER WAS CHECKED. NO REMARKS. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED AND THE DEVICE WAS TESTED WITH A RANDOM CARTRIDGE AND A NOVO NORDISK NEEDLE WAS MOUNTED. DURING TESTING IT WAS POSSIBLE TO DELIVER PREPARATION FROM THE CARTRIDGE. THE MEMORY DISPLAY MIRRORED ALL DOSE SIZES SELECTED BY RANDOM CORRECTLY. THE FUNCTION OF THE PUSH BUTTON WAS FOUND TO BE NORMAL. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE PEN HAS BEEN TESTED SYSTEMATICALLY. NO FAULTS WERE FOUND. SCANNING OF INTERNAL PEN PARTS WAS PERFORMED. THERE WERE NO VISIBLE DEFECTS INSIDE THE PEN. IT HAS NOT BEEN POSSIBLE TO FIND ANY DEFECTS IN THIS PEN. DURING ALL TESTS THE DISPLAY SHOW THE CORRECT DOSAGE DURING EXAMINATION/TEST OF THE PRODUCT IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. THE PRODUCT WAS FOUND TO BE NORMAL. THE BATCH DOCUMENTATION WAS REVIEWED. NO ABNORMALITIES RELATING TO THE OBSERVED PROBLEM WERE FOUND. THE BATCH DOCUMENTATION HAS BEEN REVIEWED. NOTHING ABNORMAL WAS FOUND.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). SEVERE HYPERGLYCAEMIA [HYPERGLYCAEMIA]. IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE [DEVICE ISSUE]. OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON [DEVICE ISSUE]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM SPAIN WAS REPORTED BY A PHARMACIST AS "SEVERE HYPERGLYCAEMIA" WITH AN UNSPECIFIED ONSET DATE, "IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE" WITH AN UNSPECIFIED ONSET DATE, "OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) YEARS OLD MALE PATIENT WHO WAS TREATED WITH NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNKNOWN START DATE DUE TO "TYPE 1 DIABETES MELLITUS". PATIENT'S WEIGHT: (B)(6). PATIENT'S HEIGHT AND BODY MASS INDEX: NOT REPORTED. MEDICAL HISTORY INCLUDED TYPE 1 DIABETES MELLITUS (DURATION UNKNOWN). DURING THE LAST WEEK (DATE UNKNOWN), THE PATIENT PRESENTED SEVERE HYPERGLYCEMIAS WITH BLOOD GLUCOSE LEVELS OF 500 (UNITS NOT REPORTED). THE PATIENT HAD 2 NOVOPEN ECHO, IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE AND THE OTHER ONE HAD PROBLEM WITH THE PUSH BOTTOM. ACTION TAKEN TO BOTH NOVOPEN ECHO WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "SEVERE HYPERGLYCAEMIA" WAS UNKNOWN. THE OUTCOME FOR THE EVENT "IN ONE THE DISPLAY SHOWED LOWER DOSE THAN THE INJECTED DOSE" WAS NOT REPORTED. THE OUTCOME FOR THE EVENT "OTHER ONE HAD PROBLEM WITH THE PUSH BUTTON" WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57017 NOVOPEN ECHO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS N/A EVG2914-4

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other 1) NOVORAPID PENFILL (INSULIN ASPART)