BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3032781 · Received April 3, 2013

    Report

    Report Number
    2531779-2013-03472
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 17, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, INDICATING THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2013, WITH A BLOOD GLUCOSE LEVEL OF 1600MG/DL WITH KETOACIDOSIS. THE PATIENT WAS UNCONSCIOUS AT THE TIME OF ADMITTANCE. DURING THE HOSPITALIZATION THE PATIENT HAD THEIR LEFT FOOT AMPUTATED. THE PATIENT REPORTEDLY RECEIVED AN EMPTY CARTRIDGE ALARM ON (B)(6) 2013 AND THE PATIENT NEVER REFILLED THE CARTRIDGE. THE REPORTER INDICATED THAT THE PATIENT SAID THEY WERE "TIRED AND DID NOT WANT TO DO IT ANYMORE." NO INSULIN WAS DELIVERED VIA THE PUMP SINCE THE EMPTY CARTRIDGE ALARM ON (B)(6). THE PATIENT HAS REPORTEDLY HAD 3 SURGERIES ON THEIR FOOT IN THE PAST TWO YEARS AND HAD A FOOT INFECTION PRIOR TO HOSPITALIZATION. THE PATIENT REPORTEDLY HAS NOT BLOUSED PROPERLY ON THE PUMP AND HAS BEEN CHANGING THE SITE EVERY 4 OR 5 DAYS AND SOMETIMES LONGER. THERE IS NO INDICATION OF A PUMP MALFUNCTION. THE PATIENT HAS DECIDED TO RESUME USE OF THE PUMP. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS RELATED TO USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137012 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L| R