BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1981023 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80285
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 40MG/DL. THE CUSTOMER STATED THAT HE WOKE UP WITH HIGH BLOOD GLUCOSE AND THEN HE CHANGED THE INFUSION SET. THE CUSTOMER STATED THAT HE TREATED HIMSELF WITH A MANUAL INJECTION OF 5 UNITS BEFORE CHANGING THE INFUSION SET. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASALS, AND BOLUS HISTORY WERE CORRECT. RAN A SELF TEST AND THE DEVICE PASSED THE TEST. THE CUSTOMER STATED FEELING UNCOMFORTABLE USING THE DEVICE AND REQUESTED A REPLACEMENT OF THE INSULIN PUMP. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization