BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3984355 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-05993
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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

    IT IS REPORTED THAT THE CUSTOMER'S INSULIN PUMP FAILED TO DELIVER INSULIN CAUSING HER TO GO INTO DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AT 594 MG/DL. THE CUSTOMER WAS HOSPITALIZED AND RECEIVED A MANUAL INSULIN INJECTION. REPORTED THAT THE PUMP IS NOT DELIVERING INSULIN EVERY FIVE MINUTES DURING BASAL DELIVERY. DATE OF URGENT CARE VISIT WAS ON (B)(6) 2014. THE CUSTOMER STATED THAT SHE WILL STAY ON MANUAL INJECTIONS UNTIL SHE UPGRADES TO A NEW PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460712 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening