BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1993010 · Received February 7, 2011

    Report

    Report Number
    2032227-2011-00381
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAW AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER STATED THAT SHE WAS NOT SPILLING KETONES, BUT WAS FEELING NAUSEATED. THE CUSTOMER HAD CHANGED THE INFUSION SET TWO DAYS EARLIER, BUT DID NOT TRY CHANGING THE INFUSION SET AGAIN TO SOLVE THE ISSUE. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. 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-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization