BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5143307 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56047
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM A39. CUSTOMER'S BLOOD GLUCOSE WAS 125 MG/DL. THE CUSTOMER IS UNABLE TO EXIT THE LOOP AND TEMP BASAL WAS PROGRAMMED BEFORE. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE CUSTOMER WAS ADVISED TO REVERT TO BACKUP PLAN. THE CUSTOMER PUMP IS OOW AND AGREED TO SENT THE OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673074 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1