BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2172479 · Received June 17, 2011

    Report

    Report Number
    2032227-2011-01454
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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'S MOTHER REPORTED THAT THE CUSTOMER HAS BEEN WAKING UP WITH HIGH BLOOD GLUCOSE LEVELS DURING THE NIGHT. THE MOTHER HAS NOTICED BENT CANNULAS, BUT THE CUSTOMER HAS NOT REC'D ANY NO DELIVERY ALARMS. THE MOTHER STATED THAT THE ONLY TIME THE INSULIN PUMP HAS ALARMED NO DELIVERY HAS BEEN DURING TROUBLESHOOTING. THE MOTHER WAS ADVISED OF THE WAY THE NO DELIVERY ALARM WORKS. ADVISED THAT DURING THE NIGHT THE CUSTOMER IS RECEIVING A VERY SMALL AMOUNT OF INSULIN VIA THE BASAL RATES, AND THE ALARM WILL BE TRIGGERED ONCE ENOUGH BACK PRESSURE HAS BUILT UP. ALSO, SUGGESTED TRYING A DIFFERENT INFUSION SET IF THE CUSTOMER HAS HAD REPEATED BENT CANNULAS. 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-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR