BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234074 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82733
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 402MG/DL. IT WAS STATED THAT PRIOR GOING TO THE HOSPITAL THE CUSTOMER WAS NOT CONNECTED BECAUSE THE INSULIN PUMP WAS SHOOTING OUT THE INSULIN DURING THE PRIME PROCESS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE SELF TEST COULD NOT BE PERFORMED BECAUSE THE INSULIN PUMP ALARMED LOW BATTERY. IT WAS STATED THAT THE PRIME TEST WAS NOT PERFORMED AS THE INSULIN PUMP WAS STUCK IN PRIME MODE. THE PROGRAMMING, TIME AND DATE WERE CORRECT. ADVISED THAT THE CUSTOMER SHOULD STAY ON 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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization