BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2083288 · Received April 13, 2011

    Report

    Report Number
    2032227-2011-00918
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS. IT WAS ALSO STATED THAT THE CUSTOMER PROGRAMMED A 4.0 UNIT BOLUS, BUT THE INSULIN PUMP DELIVERED 9.0 UNITS. TROUBLESHOOTING WAS PERFORMED, AND THE DAILY TOTALS DID NOT ADD UP CORRECTLY. THE INSULIN PUMP DID PASS THE DISPLACEMENT TEST, HOWEVER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1