BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090162 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81373
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 15, 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
    NM, 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 BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 483MG/DL. THE CUSTOMER STATED THAT SHE WAS TREATED AT THE HOSPITAL ON (B)(6) AND THEN SENT HOME. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) AGAIN. THE CUSTOMER STATED THAT SHE WAS IN INTENSIVE CARE FOR FOUR DAYS. THE CUSTOMER STATED THAT SHE ATTEMPTED TO GIVE HERSELF A MANUAL INJECTION, BUT HER GLUCOSE LEVEL ROSE QUICKLY. THE CUSTOMER STATED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST WEEK. THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND WAS TREATING WITH MANUAL INJECTIONS. THE CUSTOMER STATED THAT THE DOCTOR REQUESTED THE INSULIN PUMP TO BE REPLACED. THE CUSTOMER MENTIONED THAT THERE ARE CRACKS ON THE INSULIN PUMP DISPLAY. 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization