BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945929 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87989
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    IT WAS REPORTED THAT THE INSULIN PUMP SENT SEVERAL ALARMS, INCLUDING A BATTERY OUT LIMIT ALARM, WHICH OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE DEVICE KEEPS REWINDING AND RESETTING CONSTANTLY, SINCE THE DAY PRIOR TO THE PHONE CALL. THE CUSTOMER'S BLOOD GLUCOSE WAS 192 MG/DL. IN THE ALARM HISTORY OF THE DEVICE THERE WERE SEVERAL ALARMS, INCLUDING WEAK BATTERY AND BATTERY OUT LIMIT. DURING TROUBLESHOOTING THE CUSTOMER REMOVED THE BATTERIES TO CHECK FOR CORROSION AND THE INSULIN PUMP ALARMED WEAK BATTERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426188 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR