BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142620 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01535
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NOT 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 CALLED TO REPORT THAT THE INSULIN PUMP HAS NOT ALARMED NO DELIVERY WHEN SHE'S NOT RECEIVING INSULIN. THE CUSTOMER SOMETIMES HAS ISSUES WITH THE INFUSION SETS BEING PARTIALLY REMOVED FROM THE SITE, AND DOESN'T KNOW THAT SHE'S NOT GETTING INSULIN UNTIL HER SHIRT IS WET WITH INSULIN OR HER BLOOD GLUCOSE LEVELS ARE HIGH. ADVISED THE CUSTOMER THAT THE HIGH PRESSURE TEST COULD BE CONDUCTED TO MAKE SURE THAT THE NO DELIVERY ALARM WORKS, BUT THE CUSTOMER DIDN'T HAVE A TUBING CLAMP. A TUBING CLAMP WAS MAILED TO THE CUSTOMER, AND SHE WAS ADVISED TO CALL BACK TO CONDUCT THE HIGH PRESSURE TEST.

    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-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR