BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161994 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04941
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTION TO SUSPECT MEDICAL DEVICE SERIAL #.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE (BG) OF 764MG/DL WITH KETONES AND EMESIS. THE PATIENT REPORTEDLY WAS PLACED ON INSULIN DRIP AND HER BG WAS AT 96MG/DL. THE PUMP WAS REMOVED UPON ADMISSION. THE FAMILY MEMBER STATED THAT THERE WERE SEVERAL CALL SERVICE ALARMS WHICH DID NOT CLEAR. CUSTOMER SUPPORT WAS UNABLE TO REVIEW THE PUMP DUE TO CALL SERVICE ALARMS. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization