BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3051684 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92491
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 233MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED, AND THE DRIVE SUPPORT CAP WAS FLUSH. THE CALLER ALSO STATED THAT THE DEVICE WAS STUCK ON THE PRIME LOOP. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152284 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR