BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3093704 · Received May 6, 2013

    Report

    Report Number
    2032227-2013-01655
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT IS REPORTED BY CUSTOMER'S MOTHER THAT THE INSULIN PUMP IS STUCK IN A REWIND LOOP. THE BLOOD GLUCOSE READING IS 75 MG/DL. CUSTOMER STATED THE INSULIN PUMP HAD PHYSICAL DAMAGE. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS LOOSE AND HE HAS PUSHED IT BACK IN. ADVISED CUSTOMER NOT TO MANIPULATE OR PUSH THE DRIVE SUPPORT CAP WHILE CONNECTED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196922 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR