BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930665 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86827
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    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 OF 468 MG/DL AND HAS TREATED WITH A SYRINGE. CUSTOMER STATED THAT HE PUT IN A NEW SITE AND IS NOT ABLE TO GET ANY INSULIN. CUSTOMER REPORTED SYMPTOMS OF TIREDNESS AND THIRST. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEAR TO BE NORMAL. ALARM HISTORY SHOWED A NO DELIVERY ALARM WHILE PRIMING. THE HIGH PRESSURE TEST WAS ALSO PERFORMED AND PASSED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408857 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR