BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3033268 · Received April 3, 2013

    Report

    Report Number
    2032227-2013-01258
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RETURNED WITH NO BATTERY INSTALLED. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST. UNABLE TO CONFIRM ROOT CAUSE DUE TO INSULIN PUMP PRESERVATION. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. HOWEVER, THE INSULIN PUMP PASSED DISPLACEMENT TEST. THE INSULIN PUMP WAS RETURNED WITH PARTIALLY CRACKED END CAP AND SCRATCHES ON DISPLAY WINDOW AND BLEEDING ON THE EDGE OF LCD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AFTER BEING INVOLVED IN A MOTORCYCLE ACCIDENT. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE ACCIDENT. THE CALLER STATED THAT THE INSULIN PUMP IS CURRENTLY IN THE HANDS OF THE POLICE DEPARTMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137312 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death