BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181474 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39585
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 600 MG/DL. CUSTOMER THINKS SHE DELIVERED INSULIN BUT WAS NOT SURE. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE PUMP. CUSTOMER REPORTED CRACKS ON THE PUMP AND THAT THERE WAS A PIECE MISSING ON THE RESERVOIR COMPARTMENT. CUSTOMER WAS ASKED IF SHE HAD TREATED FOR HER BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT SHE TRIED TO HOLD THE RESERVOIR IN PLACE SO THAT INSULIN COULD BE DELIVERED, BUT WAS NOT SURE IF IT WAS. CUSTOMER WAS TRANSFERRED TO HELP LINE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661224 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR