BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4171435 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-18552
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED, FOR APPROXIMATELY THREE WEEKS, WITH PNEUMONIA, LETHARGIC, AND A COMBINATION OF THINGS. THE CUSTOMER PASSED AWAY ON (B)(6) 2014 DUE TO ANOXIC BRAIN INJURY, CARDIOPULMONARY ARREST AND PNEUMONIA. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AND HAD BEEN OFF THE DEVICE FOR THREE WEEKS. THE CALLER STATED THAT THE CUSTOMER WAS NOT TESTING AS THEY SHOULD HAVE BEEN; THEIR A1C WAS 12.9. THE CAUSE OF THE HOSPITALIZATION WAS PNEUMONIA, COMBINATION OF HIGH BLOOD GLUCOSE AND KIDNEY FAILURE, AND THEN THE CUSTOMER WENT INTO CARDIAC ARREST. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION AND AT THE TIME OF PASSING WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650682 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization