BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3841639 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02166
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO ALARMS WERE NOTED. THE PUMP HAD A SCRATCHED WINDOW DISPLAY AND CRACKS ON THE DISPLAY WINDOW CORNER AND RESERVOIR TUBE. THE PUMP ALSO HAD A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP ALARMED AND SQUIRTED INSULIN DURING THE MANUAL PRIME. ADVISED THE CALLER THAT THE PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318723 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR