BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2243558 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82842
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 347 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING, AND SHE WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST TWENTY FOUR HOURS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 200 MG/DL AND SHE HAS BEEN TREATED WITH AN INSULIN DRIP WHILE STAYING AT THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. NO FURTHER INFO 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-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization PARADIGM, 13MM| SILHOUETTE| UNOMEDICAL INFUSION SET: MMT-368