BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3892355 · Received June 24, 2014

    Report

    Report Number
    2032227-2014-03342
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-03341.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED AND HAD TWO INSULIN PUMPS CONNECTED TO HIM UPON ARRIVAL AT THE INTENSIVE CARE UNIT. THE BLOOD GLUCOSE READING WAS 60 MG/DL. THE REPORTING NURSE STATED THAT THE INSULIN PUMPS CONTINUED TO ADMINISTER INSULIN TO CUSTOMER, AND HE HAD CALLED TO FIND OUT HOW TO DISCONNECT THE PATIENT FROM THE INSULIN PUMPS PRIOR TO TREATMENT. ADVISED NURSE ON PROCEDURE FOR INFUSION SET AND RESERVOIR DISCONNECTION. WE MADE SEVERAL ATTEMPTS TO OBTAIN MORE INFORMATION REGARDING THE HOSPITALIZATION AND OTHER INSULIN PUMP, BUT WE WERE UNABLE TO REACH THE CUSTOMER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367967 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization