BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162961 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08098
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. THE USER GUIDE INSTRUCTS THE PATIENT TO DISCONNECT FROM THE PUMP PRIOR TO MANIPULATING THE CARTRIDGE CAP.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A HYPOGLYCEMIC EVENT. THE PATIENT INDICATED THAT A FAMILY MEMBER FOUND THE PATIENT LIMP WITH RAPID SHALLOW BREATHING, SOAKING WET, AND BARELY ABLE TO BE AROUSED. THE FAMILY MEMBER TREATED THE PATIENT WITH ORANGE JUICE AND CONTACTED EMERGENCY MEDICAL SERVICES. UPON EMERGENCY MEDICAL SERVICE ARRIVAL, THE PATIENT¿S BLOOD GLUCOSE WAS FOUND TO BE 72 MG/DL AND THE PATIENT WAS MORE COHERENT. THE PATIENT REPORTED THAT THE PUMP EMITTED A LOSS OF PRIME AND THE PATIENT NOTED THAT THE CARTRIDGE CAP HAD COME LOOSE. THE PATIENT REPORTED THAT THE CARTRIDGE CAP WAS TIGHTENED TO THE PUMP BUT THE SITE WAS NOT DISCONNECTED. THE PATIENT TESTED BLOOD GLUCOSE LEVELS AT THE TIME OF THE LOSS OF PRIME WARNING AND WAS ELEVATED TO 267 MG/DL SO AN EZ BG BOLUS WAS DELIVERED. WHEN THE FAMILY MEMBER WOKE UP IN THE MORNING THE PATIENT WAS LIMP AND HAD SHALLOW BREATHING. THE PATIENT WAS ADVISED ON DISCONNECTING FROM THE PUMP WHEN THE CARTRIDGE CAP IS TIGHTENED TO PREVENT INADVERTENT DELIVERY OF INSULIN. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH UNINTENDED INSULIN DELIVERY BY TIGHTENING THE CARTRIDGE CAP WHILE CONNECTED TO THE INFUSION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262650 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR