BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3873311 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85723
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLED IN TO REPORT THAT HE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE CUSTOMER FEELS THE PUMP MIGHT NOT BE WORKING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 450 MG/DL. THE SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS THAT THE CUSTOMER EXPERIENCED WERE VOMITING AND THIRST. TROUBLESHOOTING WAS PERFORMED ON THE DEVICE AND THE CUSTOMER FOUND THAT INSULIN DID EXIT DURING A MANUAL PRIME. THE CUSTOMER STATES THAT THE TIME AND DATE ARE CORRECT IN THE DEVICE. THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT AS WELL, HOWEVER, SEVERAL LOW RESERVOIR ALARMS WERE FOUND IN THE ALARM HISTORY. THE BOLUS HISTORY WAS CHECKED AND IT WAS FOUND TO BE ACCURATE. THE INFUSION SET WAS REMOVED FROM THE CUSTOMER'S BODY AND HE STATED THAT THE CANNULA WAS NOT OCCLUDED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349614 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization