BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3011708 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-91964
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 472MG/DL. TROUBLESHOOTING WAS PERFORMED. INITIALLY, THE CALLER STATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY WHILE CHANGING THE INFUSION SET OR DELIVERING A CORRECTION BOLUS, AND THE CUSTOMER WAS NOT ABLE TO USE THE DEVICE DUE TO THE ANOMALY. THE MOTHER STATED THAT THE CUSTOMER WAS GIVEN LISPRO AND THEN RELEASED. ATTEMPTED TO INSTALL A NEW BATTERY AND TO CLEAN THE BATTERY CAP AGAIN, BUT THE DISPLAY DID NOT RETURN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114146 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization