BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3112603 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93473
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. MOTOR PASSED MOTOR TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMS MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE READING IS 164 MG/DL. ASSISTED CUSTOMER WITH CLEARING THE ALARM. CUSTOMER IS ABLE TO REWIND THE INSULIN PUMP. DISPLACEMENT TEST PASSED. CUSTOMER STATED THAT MOTOR ERROR ALARM OCCURS DURING BOLUS DELIVERY. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212607 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR