BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3203198 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-95332
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 WAS SKIPPING STEPS WHEN COMPLETING THE FIXED PRIME. THE CALLER MENTIONED HAVING TROUBLE WITH LOW BLOOD GLUCOSE, AND HE BELIEVES THAT HIS MAY HAVE CONTRIBUTED TO THE DEVICE MALFUNCTIONING. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS FLUSH. ADVISED THE CALLER TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301214 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR