BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2111223 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-81406
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA, WITH A BLOOD GLUCOSE LEVEL OF 460 MG/DL. THE CUSTOMER'S PARENTS STATED THAT THERE WERE RECURRING NO DELIVERY ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS DELIVERING INSULIN PROPERLY AND PASSED THE DISPLAY VERIFICATION TEST. 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 PUERTO RICO OPERATIONS MED-REL MMT-715WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization