BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2031051 · Received March 16, 2011

    Report

    Report Number
    2032227-2011-00673
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DUE TO A FAULTY FORCE SENSOR. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE. UNABLE TO PERFORM THE BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS VISITED HER DOCTOR DUE TO BLOOD GLUCOSE LEVELS AS LOW AS 22 MG/DL. THE DOCTOR FELT THAT THE CUSTOMER WAS DOING EVERYTHING CORRECTLY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PROGRAMMED CORRECTLY. THE INSULIN PUMP APPEARED TO BE FUNCTIONING, BUT THE CUSTOMER 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization