BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070250 · Received April 18, 2011

    Report

    Report Number
    2032227-2011-00943
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 PROBLEMS WITH HIGH AND LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER THEN STATED THAT HE WAS HOSPITALIZED WITHIN THE PAST MONTH FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE WAS IN A COMA. THE CUSTOMER FELT UNCOMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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 72 YR Hospitalization