BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3971985 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88566
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP WAS DROPPED AND COULD NOT BE REWOUND. THE INSULIN PUMP HAD AN ALARM AND A LOOSE DRIVE SUPPORT CAP. THE CUSTOMER'S BLOOD GLUCOSE WAS 91 MG/DL AT THE TIME THE ISSUE WAS REPORTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448410 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1