BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1982283 · Received February 1, 2011

    Report

    Report Number
    3004209178-2011-80273
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO. MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 BACK OF THE INSULIN PUMP HAD FALLEN OFF. THE MOTHER STATED THAT THE CUSTOMER WAS ON HER WAY TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE AND A VIRUS. THE MOTHER STATED THAT HER DAUGHTER IS IN ANOTHER STATE AT SCHOOL. WHILE TRIED TO CONNECT THREE WAYS THE CALL WAS DISCONNECTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS CO. MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization