BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021576 · Received March 8, 2011

    Report

    Report Number
    2032227-2011-00611
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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, WITH A READING OF 600 MG/DL. THE CUSTOMER STATED THAT SHE MISSED A BOLUS, AND HAD A DIFFICULT TIME MAINTAINING NORMAL BLOOD GLUCOSE LEVELS AFTER THAT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE INCORRECT TIME. THE CUSTOMER STATED THAT SHE HAD RECEIVED SEVERAL ALARMS THAT REQUIRED A TIME AND DATE CHANGE, BUT SHE NEVER SET IT. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. THEY ALSO FELT THAT THE INSULIN SHE WAS USING MAY HAVE BEEN DENATURED. 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-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization