BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3771752 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-83945
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP KEPT ALARMING NO DELIVERY AS WELL MOTOR ERRORS. THE CUSTOMER WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE ALARM OCCURRED WHEN THE PLUNGER ATTEMPTED TO PUSH THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP DID NOT APPEAR TO BE DAMAGED. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250151 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization