BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841707 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-85273
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CUSTOMER REPORTED HAVING MANY HIGH BLOOD GLUCOSE READINGS. THE INSULIN PUMP IS UNDER-DELIVERING INSULIN. THE BLOOD GLUCOSE READING WAS 428 MG/DL. THE CUSTOMER WAS TREATED BY MANUAL INJECTION. THE CUSTOMER REPORTED SWOLLEN LEGS THE NIGHT BEFORE THE PHONE CALL. DURING THE TROUBLESHOOTING PROCESS IT WAS DISCOVER THAT THE INSULIN PUMP HAD SEVERAL ALARMS FOR LOW RESERVOIR AND NO DELIVERY. WHEN THE CUSTOMER REMOVED THE INFUSION SET FROM HER BODY, THE CANNULA WAS BENT. THE CUSTOMER STATED THAT FOR THE CANNULA INSERTION SITE THEY HAVE BEEN USING ABDOMEN ONLY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318798 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR