BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3884525 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03127
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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 PATIENT EXPERIENCED LOW BGS, AND NO LONGER TRUSTS THE PUMP. IT WAS STATED THAT THE PATIENT INSPECTED THE PUMP AFTER EXPERIENCING LOW BGS, AND THE RESERVOIR JUST FELL OUT OF THE RESERVOIR COMPARTMENT. TROUBLESHOOTING WAS PERFORMED, AND THE PUMP WAS PROGRAMMED CORRECTLY. ALL PUMP HISTORIES SEEMED CORRECT. HOWEVER, THE PUMP FAILED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361373 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1