BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1992957 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80347
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED TWICE IN THE PAST TWO WEEKS DUE TO LOW BLOOD GLUCOSE OF 22 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS HAVING A SEVERE HYPOGLYCEMIC EPISODE AND WAS NOT RESPONDING. THE CUSTOMER STATED THAT SHE MAY HAVE BEEN OVER RELYING ON THE INSULIN PUMP AND SHE IS ALSO PREGNANT. THE CUSTOMER STATED THAT A SETTING ON THE BOLUS WIZARD WAS CHANGED, BUT THE DEVICE DID NOT REFLECT THE CHANGE. THE CUSTOMER STATED THAT SHE IS NO LONGER COMFORTABLE WITH THE DEVICE AND A REPLACEMENT OF THE INSULIN PUMP WAS REQUESTED. 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization