BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2250055 · Received September 9, 2011

    Report

    Report Number
    2032227-2011-02275
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 28, 2011
    Report Date
    August 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 STATED THAT SHE WORE THE INSULIN PUMP DURING AN MRI SCAN, AND NOW THE INSULIN PUMP IS ALARMING MOTOR ERROR. THE CUSTOMER STATED THAT SHE WAS NOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, BUT SHE WAS TREATED WITH A MANUAL INJECTION DURING THE HOSPITALIZATION. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 287 MG/DL. ADVISED THE CUSTOMER 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization