BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233572 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-34254
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 170 MG/DL. THE CUSTOMER TREATED WITH A BOLUS FROM THE INSULIN PUMP. THE CUSTOMER INDICATED HAVING SYMPTOMS CONSISTENT WITH HIGH BLOOD GLUCOSE LEVELS INCLUDING THIRSTINESS AND LAZINESS. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPORTED NOT RECEIVING ANY KIND OF ALARM FROM THE INSULIN PUMP EVEN WHEN HE DID NOT GET ANY INSULIN. THE CUSTOMER ALSO REPORTED A BENT CANNULA ON THE INFUSION SET OF THE INSULIN PUMP. THE ALARM HISTORY OF THE INSULIN PUMP SHOWED THAT THERE WAS A NO DELIVERY ALARM AND A LOW BATTERY ALARM. THE CUSTOMER DECLINED TO FINISH TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714763 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR