BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3052408 · Received April 11, 2013

    Report

    Report Number
    2032227-2013-01325
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE OF 380 MG/DL. THE CUSTOMER FELT THAT THE INSULIN PUMP MALFUNCTIONED BECAUSE AS SOON AS HE WAS RELEASED, HE WENT BACK ON THE INSULIN PUMP AND EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED HE LEFT THE INSULIN PUMP ON A PIECE OF PAPER ALL NIGHT, AND NO INSULIN CAME OUT THE ENTIRE TIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155024 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization