BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2051854 · Received March 15, 2011

    Report

    Report Number
    2032227-2011-00655
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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

    THE CUSTOMER STATED THAT HE WOKE UP WITH A BLOOD GLUCOSE READING OF 333 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET AND NOTICED THAT THE CANNULA WAS BENT OVER. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT GIVE A NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. ALSO FOUND THAT THE CUSTOMER WAS NOT FILLING THE RESERVOIRS PROPERLY. THE CUSTOMER WAS GIVEN INSTRUCTIONS ON HOW TO FILL THE RESERVOIRS PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR