BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2033961 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80718
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HAVING A HIGH WHITE BLOOD CELL COUNT, WITH A HIGH BLOOD GLUCOSE READING OF 565 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, HE HAD BEEN EXHIBITING SYMPTOMS SUCH AS VOMITING, HIGH KETONES, FREQUENT URINATION, NAUSEA, HIGH BLOOD GLUCOSE, AND HEADACHES. THE CUSTOMER ALSO STATED THAT HE HAD CHANGED THE INFUSION SET THE SAME DAY AS THE EVENT. PROGRAMMING COULD NOT BE CONFIRMED DUE TO A BUTTON ERROR. TROUBLESHOOTING WAS PERFORMED, BUT THE FIXED PRIME WAS UNABLE TO BE COMPLETED AND THE CUSTOMER COULD NOT CLEAR THE BUTTON ERROR ALARM. 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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization