BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4192750 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41576
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 REPORTED THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART AND EXTERNAL RAM CRC ERROR. CUSTOMER WAS CHANGING THE BATTERY AND GOT UNEXPECTED RESTART ALARM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 157 MG/DL. IT WAS FOUND IN THE ALARM HISTORY THAT THERE WAS UNEXPECTED RESTART AND EXTERNAL RAM CRC ERROR ALARM. CUSTOMER WAS CONCERN THAT HE HAS TO GO THROUGH RESETTING THE TIME AND DATE, REWIND AND PRIME EVERYTIME HE CHANGES THE BATTERY. ADVISED THAT THE INSULIN PUMP IS SAFE TO CONTINUE USING. CUSTOMER WILL MONITOR THE INSULIN PUMP AND WILL INQUIRE REGARDING INSULIN PUMP UPGRADE. IT WAS MENTIONED THAT SPOUSE STATED THAT THE INSULIN PUMP HAD PHYSICAL DAMAGE. CUSTOMER STATED THERE WAS A SCRATCH ON THE SCREEN. CUSTOMER ABLE TO READ THE SCREEN AND WILL MONITOR THE INSULIN PUMP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673033 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR