BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2082718 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-81228
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 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
    CA, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED REQUESTING ASSISTANCE WITH PRIMING. THE CUSTOMER STATED THAT HE PRIMED TWICE AND THE RESERVOIR WAS EMPTIED AFTER FILLING. THE CUSTOMER'S BLOOD GLUCOSE READING AT TIME OF CALL WAS 133MG/DL, AND THEN LOWERS TO 99MG/DL WITHIN TWENTY MINUTES. IT WAS STATED THAT THE CUSTOMER'S GIRLFRIEND CALLED THE AMBULANCE. ADVISED THE CUSTOMER TO CALL BACK TO PROVIDE US MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention