BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2823277 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90614
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    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
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLEEDING LCD GLASS. UNABLE TO TEST FOR MOTOR ERROR ALARMS, OFF/NO POWER ALARMS OR TO PERFORM FUNCTIONAL TESTS INCLUDING DISPLACEMENT, PRIME, BASIC OCCLUSION, OCCLUSION AND NO DELIVERY TESTS DUE TO BLEEDING LCD GLASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP STOPPED FUNCTIONING AND ALARMED NO DELIVERY AND MOTOR ERROR. THE CUSTOMER WENT INTO DIABETES KETOACIDOSIS AND HOSPITALIZED FOR SEVERAL DAYS. IT WAS STATED THAT THE CUSTOMER INSERTED A BATTERY, AND THE INSULIN PUMP WAS UNRESPONSIVE. THE TOP OF THE SCREEN HAS A BLACK SPOT. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization