BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2870079 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08032
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO TEST FOR BOLUS STOPPED ALARMS DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP WAS TESTED WITH A TEST KEYPAD AND NO FROZEN DISPLAY NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A BOLUS STOPPED ALARM FOLLOWED BY UNRESPONSIVE BUTTONS AND A FROZEN SCREEN. THE CUSTOMER STATED THAT THE TIME ON THE SCREEN WAS NOT ADVANCING. TROUBLESHOOTING WAS PERFORMED, AND THE ISSUES WERE NOT RESOLVED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR