BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3852407 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85456
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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

    THE CUSTOMER REPORTED BEING IN THE HOSPITAL DUE TO A HEART ATTACK AND WAS TAKEN OFF THE INSULIN PUMP. THE CUSTOMER WAS UNABLE TO SET UP THE TIME/DATE AND REQUESTED ASSISTANCE WITH REPROGRAMMING THE DEVICE. THE BLOOD GLUCOSE READING WAS 400MG/DL. THE CALL WAS DISCONNECTED AND FURTHER TROUBLESHOOTING COULD NOT BE PERFORMED. THEN THE CUSTOMER CALLED BACK AND THAT THE NEEDLE BROKE OFF ON THE INFUSION SET, BUT NOT IN HER BODY, AND SHE WAS TOLD BY THE DOCTOR TO CONNECT BACK THE DEVICE. ASSISTED THE CUSTOMER WITH PRIMING, HER DEVICE, BUT THE CUSTOMER KEPT SAYING THAT SHE HAD A RESERVOIR FILLED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329112 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization