BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2508809 · Received March 8, 2012

    Report

    Report Number
    2032227-2012-05027
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 25, 2012
    Report Date
    February 25, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED ASSISTANCE WITH CHECKING THE SETTINGS. THE CUSTOMER STATED THAT SHE HAS RECENTLY EXPERIENCED UNEXPLAINED HIGH GLUCOSE AND HAS NOT BEEN WEARING THE INSULIN PUMP SINCE THREE DAYS AGO. THE CUSTOMER STATED THAT THE RESERVOIR IS INSIDE THE DEVICE. ASSISTED THE CUSTOMER WITH THE REWIND PROCESS. THE CUSTOMER RAN THE HIGH PRESSURE TEST AND THE INSULIN PUMP DID NOT ALARM. NO DELIVERY. INSTRUCTED THE CUSTOMER TO CHANGE THE INFUSION SET, AND RER-ATTEMPT TO RUN THE TEST, BUT THE INSULIN PUMP STILL DID NOT ALARM. ADVISED THE CUSTOMER TO DISCONTINUE USE AND REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR