BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5732757 · Received June 17, 2016

    Report

    Report Number
    2032227-2016-12828
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 9, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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 HAD KEYPAD ANOMALY AND PRIME/FILL ANOMALY. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 440 MG/DL. CUSTOMER STATED THAT THE BUTTON ACT GOT STUCK AND THE PUMP DELIVER THE WHOLE RESERVOIR DURING FILL TUBING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP. THE CUSTOMER INSULIN PUMP IS OOW AND WE SHALL SEND THE OOW LETTER. THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 440 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386072 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other