BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190276 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01766
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM DUE TO BLOOD GLUCOSE LEVELS OF APPROXIMATELY 900 MG/DL. THE MOTHER STATED THAT THE CUSTOMER WAS AT A PARTY PRIOR TO THE EVENT, AND THE INFUSION SET TUBING GOT CAUGHT ON A DOORKNOB, PULLING THE SET FROM THE CUSTOMER'S BODY. THE CUSTOMER DIDN'T KNOW THAT THE SET HAD BEEN PULLED OUT. SUGGESTED TO THE MOTHER TO HAVE THE CUSTOMER TRY SHORTER TUBING. ALSO EXPLAINED HOW TO LOOP THE TUBING AND TAPE IT TO THE BODY TO AVOID THE SET PULLING OFF IN THE FUTURE. 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-399