BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090397 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23090
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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 INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER STATED THAT EVERYTHING WENT BLANK EXCEPT FOR A BLACK SPOT. THE CUSTOMER HAD JUST INSERTED FRESH BATTERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 104 MG/DL. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE. THEY WERE UNABLE TO REWIND THE DEVICE. THE CUSTOMER STATED THAT APPROXIMATELY TWO TO THREE MONTHS AGO THEY HAD AN MRI AND COULD NOT RECALL IF THEY HAD REMOVED THE INSULIN PUMP PRIOR TO THE PROCEDURE .ALSO, THEY STATED THAT THEY WENT THROUGH A BODY SCAN APPROXIMATELY SIX MONTHS AGO, WHEN THEY WERE TRAVELING. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568583 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR