BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2031097 · Received March 16, 2011

    Report

    Report Number
    2032227-2011-00659
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 540 MG/DL. REVIEWED THE BOLUS AND ALARM HISTORY, AND EVERYTHING APPEARED NORMAL. THE MOTHER DECLINED FURTHER TROUBLESHOOTING, AND REQUESTED A REPLACEMENT INSULIN PUMP. THE MOTHER REPORTED THAT THERE WERE TWO CRACKS ON THE CASING. LATER, THE DIABETES EDUCATOR REPORTED THAT AFTER THE NURSES PUT THE CUSTOMER BACK ON THE INSULIN PUMP, THE CUSTOMER WENT BACK INTO DIABETIC KETOACIDOSIS. THE NURSES HAD NOT CHANGED THE INFUSION SET, AND NOTICED THAT THE INFUSION SET HAD DISCONNECTED AT THE QUICK RELEASE. THE EDUCATOR WAS GIVEN ADVICE ON WAYS TO PREVENT THIS FROM HAPPENING. 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-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization