BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4864350 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-68252
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    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 VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE MOTOR ERROR ALARMS AND NO DELIVERY ALARMS. CUSTOMER REPORTED THAT THE MOTOR ERROR ALARMS OCCURRED DURING BOLUS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS OVER 200 MG/DL. THE CUSTOMER REPORTED THAT SHE REWOUND THE INSULIN PUMP, THEN RECEIVED A NO DELIVERY ALARM FOLLOWED BY A MOTOR ERROR ALARM. CUSTOMER STATED THAT THIS HAPPENED TWICE. DURING TROUBLESHOOTING, THE CUSTOMER WAS UNABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406014 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR