BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2123138 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01416
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 25 MG/DL. THE CUSTOMER ALSO HAD PNEUMONIA. PRIOR TO THE EVENT, THE CUSTOMER HAD EXPERIENCED LOW BLOOD GLUCOSE LEVELS FOR A DAY. THE CUSTOMER STATED THAT SHE ATE LUNCH, BUT DIDN'T BOLUS FOR IT. LATER, SHE WOKE UP ON THE FLOOR. THE CUSTOMER HAS NOT WORN THE INSULIN PUMP SINCE THE HOSPITALIZATION. REVIEWED THE ALARM HISTORY, AND FOUND SEVERAL ALARMS. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE 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-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization