BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161762 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01649
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS BEEPING. THE CUSTOMER STATED THAT SHE HAD NOT WORN THE INSULIN PUMP IN A LONG TIME DUE TO BEING HOSPITALIZED FOR HER DIABETES. THE CUSTOMER WOULD NOT ELABORATE, AND DECLINED TO GIVE FURTHER INFO. ASSISTED THE CUSTOMER WITH THE NO RESERVOIR ALARM. 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-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization