BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3201170 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09492
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    ON (B)(6) 2013, THE REPORTER STATED THE PUMP EMITTED AN OCCLUSION ALARM EARLY THE PRIOR MORNING AND AGAIN THE EVENING OF THE CALL. THE REPORTER STATED THE CARTRIDGE AND TUBING WERE CHANGED AFTER THE FIRST OCCLUSION ALARM WAS RECEIVED. THE REPORTER STATED THE SITE WAS NOT CHANGED UNTIL AFTER THE SECOND OCCLUSION ALARM WAS RECEIVED. THE REPORTER STATED THE PATIENT¿S BLOOD GLUCOSE ELEVATED TO 23 MMOL/L IN THE MORNING AND HAD POSITIVE KETONES AND VOMITING. THE PATIENT WAS TREATED WITH A BOLUS INJECTION AND THE BG RESOLVED TO 11 MMOL/L. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PUMP ALARMED APPROPRIATELY FOR OCCLUSION; THE PATIENT EXPERIENCED ELEVATED BG AS A RESULT OF USE ERROR IN NOT CHANGING THE SITE/SET/CARTRIDGE WITH THE FIRST OCCLUSION ALARM AS PER THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303264 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR