BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841728 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02680
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    CUSTOMER REPORTED HIGH BLOOD GLUCOSE LEVELS AND A MAXIMUM FILL REACHED ALARM ON THE INSULIN PUMP. HE ADMINISTERED 4 UNITS OF INSULIN TO HIMSELF, BUT IT DID NOT CHANGE HIS BLOOD GLUCOSE LEVEL. HE DID NOT CONTACT HIS HEALTHCARE PROVIDER FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 310 MG/DL. CUSTOMER ALSO REPORTED SYMPTOMS OF GROGGINESS AND TREATED WITH THE PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319276 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR