BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3231455 · Received July 17, 2013

    Report

    Report Number
    2032227-2013-02932
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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

    THE INSULIN PUMP ALARMED DURING BASIC OCCLUSION DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. SEVERELY CRACKED CASE ON LCD DISPLAY WINDOW CORNERS AND MISSING END CAP STICKER NOTED.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE OF 310 MG/DL AND THE INSULIN PUMP DRIVE SUPPORT CAP IS STICKING OUT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331265 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR