BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2121451 · Received June 7, 2011

    Report

    Report Number
    3004209178-2011-81678
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED IN INTENSIVE CARE FOR DIABETIC KETOACIDOSIS AND THE INABILITY TO WALK WHILE HE WAS TRAVELING IN ITALY. THE CUSTOMER STATED PRIOR TO THE EVENT, HE HAD BEEN SUFFERING FROM WORK-RELATED STRESS AND HAD BEEN IN A RUSH THROUGH OUT THE DAY. THE CUSTOMER ALSO STATED THAT HE HAD BLANK DISPLAY ANOMALY THAT HAD BEEN RESOLVED BY HAVING THE BATTERY CAP REPLACED. MORE RECENTLY, THE CUSTOMER STATED THAT HE HAD RECEIVED A NO DELIVERY ALARM AND THEN TWO MOTOR ERROR ALARMS WHILE TRYING TO FIX THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST BUT GAVE A MOTOR ERROR ALARM DURING PRIMING. THE CUSTOMER MENTIONED THAT HE WAS UNABLE TO PUSH INSULIN INTO THE TUBING. IT WAS THEN FOUND THAT CHANGING THE INFUSION SET RESOLVED THIS ISSUE. 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 PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization