BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2082042 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-81201
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 RECEIVED A MOTOR ERROR ALARM ON HER INSULIN PUMP. THE CUSTOMER STATED THAT THE ALARM OCCURRED DURING BOLUS PROGRAMMING. EACH TIME, THE CUSTOMER STATED, SHE WAS ABLE TO FIRST REWIND THE INSULIN PUMP, FILL THE TUBING, AND CONNECT TO THE INSULIN PUMP WITHOUT ANY PROBLEMS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. 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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR