BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2090940 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01116
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BATTERY OUT LIMIT ALARM AND UNRESPONSIVE BUTTONS. THE CUSTOMER STATED THAT THE INSULIN PUMP GOT WET. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. THE CUSTOMER STATED THAT SHE WOULD BE GOING TO THE EMERGENCY ROOM TO TREAT HER BLOOD GLUCOSE LEVELS OF 200 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization