BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2021566 · Received March 8, 2011

    Report

    Report Number
    2032227-2011-00612
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 588 MG/DL. THE CUSTOMER ALSO HAD KETONES, VOMITING AND DRY MOUTH. THE CUSTOMER WAS PUT BACK ON THE INSULIN PUMP, BUT HER BLOOD GLUCOSE LEVELS KEPT ELEVATING. TROUBLESHOOTING WAS PREFORMED, AND THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE HEALTHCARE PROFESSIONAL ADVISED THE CUSTOMER TO HAVE THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization