BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112794 · Received April 29, 2011

    Report

    Report Number
    3004209178-2011-81282
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 26, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THAT THE INSULIN PUMP DELIVERED 20.5 UNITS OF INSULIN WHILE THE CUSTOMER WAS SLEEPING. IT WAS STATED THAT THE CUSTOMER STATED DOES NOT FEEL SAFE WITH THE INSULIN PUMP BECAUSE IT DELIVERED THE 20.5 UNITS BY ITSELF. IT WAS ALSO STATED THAT THE DEVICE ALARMED NO DELIVERY DURING A BOLUS AND SOMETIMES IT DOES DURING THE BASAL. TROUBLESHOOTING WAS PERFORMED. THE DAILY TOTALS AND HER BASALS VARY FROM DAY TO DAY. IT WAS STATED THAT HER DAILY TOTALS ARE ALWAYS DIFFERENT BECAUSE OF THE SHIFT SHE DOES. THE CUSTOMER STATED THAT SHE IS REUSING THE RESERVOIRS INSTEAD OF CHANGING THEM EVERY THREE DAYS, SHE CHANGES EVERY SIX DAYS. EXPLAINED THAT THE RESERVOIR SHOULD BE CHANGE EVERY TIME THE INFUSION SET IS CHANGED. ADVISED THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    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-522CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization