BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3100619 · Received May 8, 2013

    Report

    Report Number
    2032227-2013-01729
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    February 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 STATED THAT SHE RECEIVED A REPLACEMENT INSULIN PUMP, AND THOUGHT THAT IT WAS ALREADY PROGRAMMED. THE CUSTOMER WORE IT FOR ABOUT A MONTH, AND ENDED UP IN THE HOSPITAL WITH DIABETIC KETOACIDOSIS, AND IN A COMA. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS WERE GREATER THAN 300 MG/DL. THE CUSTOMER ALSO STATED THAT SHE WAS IN A CAR ACCIDENT TWO DAYS AFTER BEING RELEASED FROM THE HOSPITAL DUE TO A RAIN STORM. THE CUSTOMER ALSO EXPERIENCES SEIZURES, MEMORY LOSS, HEART ATTACKS, AND HAS CANCER. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE PRIME AND SELF TESTS, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. FOUND THAT THE CUSTOMER HAD BEEN WEARING THE INFUSION SETS FOR UP TO SEVEN DAYS. ADVISED TO CHANGE INFUSION SET EVERY TWO TO THREE DAYS. THE CUSTOMER IS IN THE PROCESS OF GETTING A NEW INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200573 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization