BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3240704 · Received July 22, 2013

    Report

    Report Number
    2032227-2013-03071
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A CRACKED CASE WINDOW DISPLAY CORNER, RESERVOIR TUBE AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURN FOR ANALYSIS AND 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 THE INSULIN PUMP IS ALARMING, SQUIRTING THE INSULIN OUT DURING THE MANUAL PRIME AND THAT THE DRIVE SUPPORT CAP IS STICKING OUT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341663 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR