BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2232469 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-82682
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 987MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING PRIOR TO HER ADMISSION, PASSED OUT, AND A CO-WORKER FOUND HER ON THE FLOOR. IT WAS STATED THAT THE CUSTOMER WAS IN INTENSIVE CARE UNIT AT THE TIME OF CALL AND SHE SEEMS INCOHERENT. IT WAS STATED THAT THE BATTERY WAS INSTALLED AND THE INSULIN PUMP ALARMED NO DELIVERY. THE ALARM WAS CLEARED, BUT THEN THE INSULIN PUMP HAD A BATTERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization