BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3842365 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02654
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 PATIENT CALLED TO REPORT HIGH BLOOD GLUCOSE LEVELS. THE PATIENT HADN'T CONTACTED THEIR DOCTOR BECAUSE THEY WERE ABLE TO TREAT WITH INSULIN. THE CUSTOMER SAID THE SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS THAT HE EXPERIENCED WAS FATIGUE. THE CUSTOMER FOUND DURING TROUBLESHOOTING THAT THERE WAS AN ABSENCE OF THE NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 166 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE ROSE TO 180 MG/DL TO 190 MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320718 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR