BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 1981035 · Received February 2, 2011

    Report

    Report Number
    3004209178-2011-80297
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 FOR HIGH GLUCOSE OF 432 MG/DL. THE CUSTOMER STATED THAT SHE WAS DIAGNOSED WITH ABDOMINAL PAIN. THE CUSTOMER STATED THAT SHE WAS THROWING UP AND THOUGHT SHE MIGHT HAVE THE FLU. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET THE DAY BEFORE THE EVENT. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND IT WAS CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. 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 35 YR Hospitalization