BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090139 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81371
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. ADVISED THE CUSTOMER TO REMOVE THE BATTERY AND LET THE DEVICE TO REST FOR TWO HRS. THE CUSTOMER CALLED BACK AND STATED THAT HE PASSED OUT FOUR DAYS AGO AND THE INSULIN PUMP MAY HAVE BEEN PUMPED. THE CUSTOMER STATED THAT HE WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER BLOOD GLUCOSE READING WAS 400MG/DL. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization