BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4151456 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-34602
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    July 26, 2014
    Report Date
    September 8, 2014
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    THE INSULIN PUMP RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP. MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT ALARMED DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S SENSOR INSULIN PUMP DISPLAYED A MOTOR ERROR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE CAUSES FOR THE ALARM. THE PATIENT ALSO REPORTED A LOOSE DRIVE SUPPORT CAP. DEVICE IS BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632458 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR