BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162590 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08083
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED 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. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS STATING THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) VALUE IN THE 400 MG/DL TO 500 MG/DL RANGE. THE PATIENT REPORTEDLY WAS TREATED WITH A CORRECTION INJECTION. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY AND A ¿LOW CARTRIDGE¿ ALARM WAS NOTED IN PUMP HISTORY. THE TOTAL DAILY DOSE PUMP HISTORY REPORTEDLY ONLY REVEALED 13.97 AND 32.2 UNITS OF INSULIN GIVEN ON (B)(6) 2013; THE PATIENT¿S BG WAS REPORTEDLY HIGHER ON BOTH DAYS. THE PUMP REPORTEDLY WAS SUSPENDED FOR 12 HOURS AND 8 HOURS. THE PATIENT REPORTEDLY SUSPENDED THE PUMP DURING PHYSICAL EXERCISE AND WOULD FORGET TO RESUME PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. USE ERROR CONTRIBUTED TO THE REPORTED EVENT BECAUSE THE PATIENT SUSPENDED THE PUMP MULTIPLE TIMES AND WOULD FORGET TO RESUME THE PUMP FOR INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262913 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR