BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021293 · Received March 7, 2011

    Report

    Report Number
    2032227-2011-00557
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 FOR HIGH BLOOD GLUCOSE LEVELS AND SIGNS OF DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 645 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND VERIFIED THAT THE BASAL RATES WERE PROGRAMMED, BUT THE CUSTOMER DIDN'T KNOW IF THEY WERE CORRECT. THE CUSTOMER ALSO STATED THAT SHE USUALLY HAS BENT CANNULAS AND BLOOD AT THE INSERTION SITES. ADVISED THAT SHE MIGHT BE USING THE WRONG INFUSION SETS FOR HER BODY TYPE. THE INSULIN PUMP INITIALLY FAILED THE PRIME TEST. DURING THE SECOND ATTEMPT, THE CALL WAS DISCONNECTED. ATTEMPTED TO CALL THE CUSTOMER BACK, BUT THERE WAS NO ANSWER. 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-722RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization