BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142377 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01519
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 580 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING, AND SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST 24 HOURS. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. THE CUSTOMER STATED THAT SHE PROGRAMS A 10.0 UNIT BOLUS, BUT ONLY RECEIVES 1.0 UNITS. THE CUSTOMER STATED THAT IN THE BOLUS HISTORY, IT SHOWS THAT SHE RECEIVED 10.0, BUT SHE IS SURE SHE IS NOT GETTING THAT AMOUNT. THE CUSTOMER DECLINED ANY TROUBLESHOOTING, AND REQUESTED A REPLACEMENT INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization