BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182464 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-82184
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 33MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST TWO WEEKS AND WAS TREATED WITH MANUAL INJECTIONS. IT WAS STATED THAT THE INSULIN USED WITH MANUAL INJECTIONS IS THE SAME AS FILLED IN THE RESERVOIRS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 359MG/DL AND WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. PERFORMED A HIGH PRESSURE TEST TWICE AND THE INSULIN PUMP FAILED THE TEST. ADVISED TO REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. 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 9 YR Hospitalization SILHOUETTE 23"| UNOMEDICAL INFUSION SET