BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252059 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52695
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THAT HE ENTERED HIS BLOOD GLUCOSE VALUE AND CARBOHYDRATES FOR DINNER. CUSTOMER STATED THAT HE USUALLY HAS A SNACK LATER AND HIS BLOOD GLUCOSE VALUE WAS 179 MG/DL BUT CUSTOMER NOTICED THAT THE READING DONE EARLIER WAS NOT IN THE INSULIN PUMP. CUSTOMER INQUIRED IF THERE WAS ANY OTHER WAY TO SHOW THAT THE INSULIN PUMP GAVE HIM THE CORRECTION OTHER THAN THE BOLUS HISTORY. CUSTOMER WAS ADVISED HE COULD UPLOAD THE INFORMATION TO CARELINK. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736618 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR