BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3073655 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01507
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP GAVE HIM TWO MOTOR ERROR ALARMS DURING THE REWIND PROCESS. HAD THE CUSTOMER INSPECT THE DRIVE SUPPORT CAP, AND HE STATED THAT IT WAS PROTRUDING. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. HOWEVER, THE CUSTOMER STATED THAT THERE WAS NO NEED TO SEND AN INSULIN PUMP AS HE WOULD BE USING HIS BACK UP INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175138 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR