BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2040043 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-80805
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HAVE BEEN NO "NO DELIVERY" ALARMS FOR THE LAST TWO WEEKS. THE CUSTOMER STATED THAT WHEN THE RESERVOIR IS HALF EMPTY, HER BLOOD GLUCOSE LEVELS BECOME ELEVATED. THE CUSTOMER THEN STATED THAT SHE HAS USED DIFFERENT RESERVOIRS FROM DIFFERENT BATCHES AND THE PROBLEMS STILL OCCUR AFTER HALF A DAY. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE SELF-TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522WWL

    Patients

    Seq Age Sex Outcome Treatment
    1