BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4211947 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45368
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, EXCESSIVE NO DELIVERY TEST AND BASIC OCCLUSION TEST. HOWEVER, INSULIN PUMP WAS UNABLE TO PRIME UNIT DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. NO UNEXPECTED NO DELIVERY ALARMS NOTED. NO MOTOR ERROR ALARMS NOTED. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED MULTIPLE MOTOR ERROR ALARMS AND NO DELIVERY ALARMS OVER THE COURSE OF A MONTH. THE CUSTOMER'S BLOOD GLUCOSE LEVELS ARE UNKNOWN. STANDARD TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD. THE CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693758 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR