BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN ECHO

    MDR report key: 4223843 · Received October 31, 2014

    Report

    Report Number
    9681821-2014-00042
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    NOVO NORDISK A/S - DEVICE MANUFACTURING AND SOURCI
    Product Code
    FMF
    PMA / PMN Number
    K123766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY AND INVESTIGATION RESULTS: NOVOPEN ECHO, BATCH: DV40081, INV-0127387; NOVOPEN ECHO, BATCH: DV40082, INV-0127387: THE ELECTRONIC REGISTER WAS CHECKED. VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. IT WAS NOT POSSIBLE TO OBSERVE THE ALLEGED FAULT ON THE ELECTRONIC DISPLAY FUNCTION. 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 WITHOUT ANY OBSERVED PROBLEMS. THE DOSE ACCURACY WAS MEASURED BY WEIGHING USING A RANDOM PENFILL CARTRIDGE. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. IT WAS NOT POSSIBLE TO OBSERVE ANY OF THE ALLEGED FAULTS. 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 TEST OF THE DEVICE IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. A BATCH TREND REPORT HAS BEEN CREATED. NOTHING ABNORMAL WAS FOUND. FINAL COMMENT FROM THE MANUFACTURER: (B)(4) 2014. THE NOVOPEN ECHO'S HAVE BEEN RETURNED TO NOVO NORDISK (B)(4) AND THE INVESTIGATIONS SHOWED THAT BOTH PENS WERE WORKING ACCORDING TO SPECIFICATIONS. HOWEVER DUE TO LIMITED INFORMATION ON HOW THE PATIENT/USER WAS HANDLING THE PEN WAS AVAILABLE IN THE CASE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT-CAUSE FOR THE EXPERIENCED ADVERSE EVENTS OR FIND SIMILAR CASES TO (B)(4).

    Description of Event or Problem · 1

    ELEVATED BG-LEVELS [BLOOD GLUCOSE INCREASED]; PISTON ROD WASHER AND THE PISTON ROD WERE DEFECTIVE, PISTON ROD FALLS BACK; DISPLAY DOESN'T SHOW HOURS [DEVICE MALFUNCTION]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS CASE FROM (B)(6) WAS REPORTED BY A CONSUMER (PATIENT'S MOTHER) AND LATER CONFIRMED BY THE MEDICAL DOCTOR AS "ELEVATED BG-LEVELS" WITH AN ONSET DATE BETWEEN (B)(6) 2014 AND "PISTON ROD WASHER AND THE PISTON ROD WERE DEFECTIVE, PISTON ROD FALLS BACK; DISPLAY DOESN'T SHOW HOURS" WITH AN UNSPECIFIED ONSET DATE, AND CONCERNED A (B)(6) MALE PATIENT WHO WAS TREATED WITH TWO NOVOPEN ECHO (INSULIN DELIVERY DEVICE) FROM UNSPECIFIED DATE DUE TO TYPE 1 DIABETES MELLITUS. (B)(6). MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS SINCE (B)(6) 2014. THE PATIENT WAS USING THE PEN SINCE 2 TO 4 WEEKS. BETWEEN (B)(6) 2014, THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL IN THE MORNING AND 400 MG/DL IN THE EVENING. IT WAS REPORTED THAT THERE WAS INCREASING NEED OF INSULIN FOR SEVERAL DAYS AND THE END OF REMISSION PHASE SUSPECTED. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO HIGH BLOOD GLUCOSE WITH OVER 600 MG/DL. IT WAS REALISED, THAT THE PISTON ROD WASHER AND THE PISTON ROD WERE DEFECTIVE FOR BOTH PENS; PISTON ROD FELL BACK, AND DISPLAY DID NOT SHOW HOURS. IN THE HOSPITAL, IT WAS REALISED, THAT THE PISTON ROD WASHER AND PISTON ROD WERE NOT CONNECTED AND THERE WAS A GAP OF SEVERAL MILLIMETRES BETWEEN BOTH. IT WAS THE FIRST TIME THAT THE PENS HAD BEEN USED WITH A CARTRIDGE AND THE PENS HAVE NOT BEEN REOPENED AFTER INSERTION OF CARTRIDGE. CARTRIDGES WERE INTACT FUNCTION TEST WAS PERFORMED; IT WAS UNKNOWN WHETHER 20 UNITS WERE DELIVERED. PENFILL HOLDER DID NOT LOOSEN FROM PEN BODY AT ANY TIME. THE PATIENT RECEIVED NEW PENS THAT DAY. IT WAS REPORTED THAT THE PATIENT WAS A TRAINED USER OF DEVICE. THE PATIENT EITHER USED NOVOPEN ECHO HIMSELF OR THE PATIENT'S MOTHER INJECTED THE PATIENT. ACTION TAKEN TO NOVOPEN ECHO WAS THAT THE PENS WERE RETURNED TO NOVO NORDISK FOR INVESTIGATION. THE PATIENT STOPPED USING BOTH THE PENS FROM (B)(6) 2014 AND RECEIVED NEW PENS ON (B)(6) 2014. THE OVERALL OUTCOME OF"ELEVATED BG LEVELS" WAS REPORTED AS RECOVERED ON (B)(6) 2014. THE OVERALL OUTCOME OF "PISTON ROD WASHER AND THE PISTON ROD WERE DEFECTIVE, PISTON ROD FALLS BACK; DISPLAY DOESN'T SHOW HOURS LEVELS" WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698115 NOVOPEN ECHO INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S - DEVICE MANUFACTURING AND SOURCI NA DV40081

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization