BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2133302 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-81415
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT THE INSULIN PUMP OVER-DELIVERED INSULIN. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER'S SCHOOL NURSE ASSISTED THE CUSTOMER BY BOLUSING 1.1 UNITS OF INSULIN TO THE CUSTOMER, BUT INSTEAD THE INSULIN PUMP DELIVERED A BOLUS OF 9.9 UNITS BEFORE THE CUSTOMER'S MOTHER COULD STOP THE INSULIN PUMP. THE CUSTOMER'S MOTHER ALSO STATED THAT THE SCHOOL NURSE HAD NOT PRESSED ANY BUTTONS. THE CUSTOMER'S MOTHER FURTHER STATED THAT AFTER UPLOADING THE INSULIN PUMP DATA TO THE CARELINK MONITORING SOFTWARE, THE BOLUS ESTIMATE SHOWED 0.0 UNITS INSTEAD OF THE 9.9 UNITS THAT WERE DELIVERED. 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 PUERTO RICO OPERATIONS MED-REL MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR