BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2060581 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-80977
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HYPERGLYCEMIA AND SOME KETONES. THE CUSTOMER STATED THAT SHE TREATED HERSELF AND THAT HER BLOOD GLUCOSE READING WAS 20 MMOL/L. THE CUSTOMER ALSO STATED THAT SHE CHANGES HER INFUSION SET EVERY THREE TO FOUR DAYS AND THAT SHE USES A MODEL MMT-399 QUICK-SET INFUSION SET. IT WAS EXPLAINED THAT INFUSION SETS NEED TO BE CHANGED EVERY TWO TO THREE DAYS. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME BUT FAILED THE HIGH PRESSURE TEST TWICE. 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-754CAB

    Patients

    Seq Age Sex Outcome Treatment
    1