BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3192635 · Received June 27, 2013

    Report

    Report Number
    2032227-2013-02585
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 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 ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP GAVE A MOTOR ERROR ALARM WHEN HE ATTEMPTED TO TREAT A HIGH BLOOD GLUCOSE OF 368 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE DISPLACEMENT TEST. THE CUSTOMER INSPECTED THE DRIVE SUPPORT CAP, AND IT DID NOT APPEAR DAMAGED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292546 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR