BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2990683 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91600
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED BUTTON ERROR FOLLOWED BY INTERMITTENT BUTTONS DUE TO FLATTENED EXPRESS BUTTON DOME SWITCH. THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE OF 320MG/DL. THE CUSTOMER STATED THAT HE WAS ADMITTED ALSO FOR A PROCEDURE THAT WAS GOING TO BE DONE OUTPATIENT. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP WAS MALFUNCTIONING AND HE ENDED UP IN THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE HAD A BUTTON ERROR ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93275 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-515NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization