BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2984088 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-91450
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OVER 400MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH A MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND BAD BATTERY, LOW RESERVOIR AND NO DELIVERY ALARMS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. PERFORMED THE HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CALLER TO REMOVE THE CANNULA AND IT WAS BENT. INSTRUCTED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86739 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR