BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2051827 · Received March 15, 2011

    Report

    Report Number
    2032227-2011-00644
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE LEVELS DUE TO INCONSISTENT INSULIN DELIVERY FROM THE INSULIN PUMP. THE CUSTOMER NO LONGER TRUSTS THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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 39 YR