BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4853482 · Received June 18, 2015

    Report

    Report Number
    2032227-2015-19375
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    May 30, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A NO DELIVERY ALARM DURING A MANUAL PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT WITH A PUSH PLUNGER. IT WAS ALSO FOUND THE INSULIN PUMP ALARMED NO DELIVERY WITH A MANUAL PRIME. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396740 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR