BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIM REVEL INSULIN INFUSION PUMP

    MDR report key: 2234053 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02189
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT SHE WAS IN A DIABETIC COMA AT THE TIME OF ADMISSION. THE CUSTOMER STATED THAT HER DOCTOR REQUESTED TROUBLESHOOTING IN PERSON. THE LOCAL REPRESENTATIVE WAS CONTACTED, AND THE INSULIN PUMP WAS LOOKED AT. HOWEVER, THE CUSTOMER DID NOT GIVE DETAILS ABOUT THE TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIM REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization