BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161734 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01675
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 59 MG/DL. THE CUSTOMER STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE LEVELS FOR THE PAST DAY, AND TREATED WITH SODA PRIOR TO THE HOSPITALIZATION. THE CUSTOMER STATED THAT HER LOW BLOOD GLUCOSE LEVELS HAVE BEEN AT THE SAME TIME EVERYDAY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER TO REVIEW THE INSULIN PUMP SETTINGS WITH HER HEALTHCARE PROFESSIONAL. 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 59 YR Hospitalization