BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123420 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29675
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS BROKEN; THERE WERE LOTS OF CRACKS AND CERTAIN BUTTONS WERE UNRESPONSIVE, THERE WAS A CRACK AROUND THE RESERVOIR, THE PLASTIC OF THE BATTERY COMPARTMENT, WHERE THE BATTERY SCREWS IN, WAS BROKEN, THE RE WERE SCRATCHES AROUND THE SCREEN, AND A LARGE CRACK ON THE UPPER RIGHT SIDE OF THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600314 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR