BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4132255 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31025
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A MOTOR ERROR ON THE INSULIN PUMP, AFTER A BOLUS WAS PROGRAMMED. THE CUSTOMER'S BLOOD GLUCOSE WAS 510 MG/DL, WHICH WAS TREATED WITH A MANUAL BOLUS. DURING TROUBLESHOOTING, IT WAS STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE INSULIN PUMP. THE REWIND SEQUENCE WAS COMPLETED ON THE INSULIN PUMP AND IT WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612123 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR