BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2234077 · Received August 29, 2011

    Report

    Report Number
    3004209178-2011-82740
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 536MG/DL. IT WAS STATED THAT THE CUSTOMER HAD RENAL INSUFFICIENCY AND UNCONTROLLED DIABETES. THE CUSTOMER STATED THAT THE EVENT LEADING TO HIS ADMISSION WAS VOMITING. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST FEW DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 167MG/DL, AND HE HAS TREATED WITH MANUAL INJECTIONS WHILE STAYING AT THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED AND HIGH PRESSURE TEST AND THE TEST 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization