BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2200760 · Received July 27, 2011

    Report

    Report Number
    3004209178-2011-82304
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    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 480MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST FEW DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 270MG/DL, AND SHE WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND 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 MIO SET: 23", 6MM BLUE| 6MM BLUE| UNOMEDICAL INFUSION SET: MMT-943