BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4153740 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35431
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    CUSTOMER REPORTED SHE WAS HAVING ISSUES WITH HER TRANSMITTER NOT CHARGING. SHE HAD RECEIVED A REPLACEMENT CHARGER. CUSTOMER CHARGED THE TRANSMITTER FOR SEVERAL HOURS, BUT THE ISSUE PERSISTS. CUSTOMER STATED HER BLOOD GLUCOSE WAS 49 MG/DL LAST NIGHT, AND TODAY IT IS 249 MG/DL. SHE DECLINED TROUBLESHOOTING FOR HIGH AND LOW BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631877 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention