BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2832554 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-90776
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. HOWEVER, THE DEVICE PASSED THE PRIME TEST AND THE NUMBERS WERE NOT RAMPIN ON THEIR OWN. THE MOTOR PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN SQUIRTED OUT AND THE NUMBERS WERE NOT RAMPING UP. THEN THE CUSTOMER CALLED BACK AND STATED THAT THE ROUND PLASTIC PART AT THE BOTTOM OF THE INSULIN PUMP WAS PUSHED OUT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR