BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3970003 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88392
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVELS AND THAT THE O-RING IN THE RESERVOIR CAME OUT. THE BLOOD GLUCOSE READING WAS 54 MG/DL. THE CUSTOMER STATED THAT SHE DID NOT HAVE TIME TO TROUBLESHOOT FOR THE ISSUE. SHE REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE, AND WHEN SHE CHANGED HER INFUSION SITE, SHE REPORTED THAT HER BLOOD GLUCOSE LEVELS DROPPED. CUSTOMER WAS IN A HURRY; ADVISED CUSTOMER TO CALL BACK TO TROUBLESHOOT FOR POSSIBLE DAMAGE TO THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446551 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 50 YR