BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3063532 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04417
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE TUBING HAD BECOME DISCONNECTED FROM THE CARTRIDGE FOR AN UNSPECIFIED AMOUNT OF TIME AND HER BLOOD GLUCOSE (BG) ELEVATED TO 450MG/DL WITH SLIGHT LIGHTHEADEDNESS. THE PATIENT STATED SHE NOTICED THE ISSUE WHEN SHE WENT TO DELIVER A BOLUS TO COVER DINNER. THE PATIENT STATED SHE TREATED HER ELEVATED BG WITH A CORRECTION INJECTION. THE PATIENT STATED SHE WAS SURE THE TUBING WAS PROPERLY CONNECTED TO THE CARTRIDGE WHEN SHE PERFORMED THE SITE/SET/CARTRIDGE CHANGE AND TROUBLESHOOTING FOUND THAT THE PATIENT WAS USING THE CARTRIDGE PER INSTRUCTIONS FOR USE. THE CARTRIDGE AND TUBING HAD BEEN DISCARDED AND WERE UNAVAILABLE FOR TROUBLESHOOTING. THE PATIENT REPORTEDLY CHANGED SUPPLIES AND CONTINUED INSULIN PUMP THERAPY. THE REPORTED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED CARTRIDGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166006 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR