BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981840 · Received February 2, 2011

    Report

    Report Number
    2032227-2011-00311
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    September 11, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. PRIOR TO THE EVENT, THE CUSTOMER PROGRAMMED A BOLUS, BUT THE INSULIN PUMP DIDN'T DELIVER IT INITIALLY. THEN, SUDDENLY, IT DELIVERED THE ENTIRE AMOUNT AT ONCE. THE CUSTOMER ALSO REPORTED THAT THE MOTOR DOES NOT STOP MOVING WHEN SHE RELEASE THE ACT BUTTON DURING THE MANUAL PRIME. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED.

    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-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization