BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234063 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02200
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 TO REPORT A NO DELIVERY ALARM DURING A MANUAL PRIME. FOUND THAT THE CUSTOMER WAS CONNECTED TO THE INFUSION SET DURING THE PRIME, AND THE RESERVOIR WAS NOW COMPLETELY EMPTY. THE PARAMEDICS WERE CALLED AS THE CUSTOMER MAY HAVE DELIVERED A LARGE AMOUNT OF INSULIN INTO HIS BODY. DURING THE CALL, THE CUSTOMER DRANK APPLE JUICE. THE PARAMEDICS ARRIVED DURING THE CALL. ADVISED THE CUSTOMER TO CALL BACK AFTER TREATMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention