BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142397 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01526
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 HAS EXPERIENCED UNEXPLAINED LOW BLOOD GLUCOSE LEVELS FOR THE PAST TEN DAYS. IT WAS ALSO STATED THAT THE CUSTOMER WAS TREATED BY THE PARAMEDICS. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS TWO DAYS AGO, AND SHE WAS NOT CONNECTED TO THE INFUSION SET DURING THE MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO CORRECT. THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CALLER WITH CORRECTING THE TIME AND DATE. 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 MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention