BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3043343 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03847
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT REQUESTED BACK, AS THERE WAS NO PRODUCT DEFECT FOUND. THE REPORTED INCIDENT HAS BEEN ATTRIBUTED TO USE OF THE PUMP WITHOUT A CARTRIDGE CAP; THERE WAS NO MALFUNCTION ALLEGED AGAINST THE PUMP OR THE CARTRIDGE CAP.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS ALLEGING THAT HE LOST THE CARTRIDGE CAP THE PREVIOUS DAY AND AWOKE THE MORNING OF (B)(6) 2013 WITH ELEVATED BLOOD GLUCOSE (BG) OF 480MG/DL WITH INCREASED THIRST AND INCREASED URINATION. THE PATIENT WAS REPORTEDLY ABLE TO BOLUS WITH THE PUMP BY HOLDING THE CARTRIDGE TIGHTLY AND HIS BG CAME DOWN TO 213MG/DL. THE PATIENT WAS ADVISED TO ORDER A NEW CARTRIDGE CAP AND TO COME OFF THE PUMP AND USE A BACK-UP PLAN FOR INSULIN DELIVERY UNTIL THE NEW CARTRIDGE CAP ARRIVED. THERE WAS NO PUMP DEFECT ALLEGED OR IDENTIFIED; THE CAUSE OF THE REPORTED BG EXCURSION WAS DETERMINED TO BE CONTINUED USE OF THE PUMP WITHOUT THE CARTRIDGE CAP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY WITH A MISSING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146267 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening