BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3143392 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07539
    Date Received
    June 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT¿S MOTHER/REPORTER CONTACTED ANIMAS ON BEHALF OF THE LAY-USER/PATIENT, ALLEGING THAT THE PATIENT REQUIRED HCP TREATMENT FOR A BLOOD GLUCOSE READING OF 600 MG/DL AND HAD KETONES AFTER THE ANIMAS INSULIN PUMP COULD NOT POWER ON. THE PATIENT REPORTEDLY WAS NOT FEELING WELL WHEN HIS BLOOD GLUCOSE WAS ELEVATED. THE PATIENT RECEIVED IV FLUID AND WAS SENT HOME AT 2 AM. THE SUBJECT PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING. THE BATTERY ON THE INSULIN PUMP WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REQUIRED HCP TREATMENT FOR HYPERGLYCEMIA AFTER THE SUBJECT INSULIN PUMP WAS FOUND TO HAVE A POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245211 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR