BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2802017 · Received October 23, 2012

    Report

    Report Number
    2032227-2012-07512
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLED TO REPORT THAT HER BLOOD GLUCOSE READING WAS NOT TRANSFERRING OVER FROM THE GLUCOSE METER TO THE INSULIN PUMP. FOUND THAT THE METER OPTION WAS TURNED OFF. THE CUSTOMER ALSO STATED THAT SHE WAS NOT FEELING WELL. THE CUSTOMER WAS EXPERIENCING HOT AND COLD FLASHES, DIZZINESS AND A HIGH BLOOD GLUCOSE READING OF 216 MG/DL. THE PARAMEDICS WERE CALLED FOR THE CUSTOMER, AND THEY ARRIVED DURING THE CALL. THE PARAMEDICS STATED THAT THEY WOULD BE ASSISTING THE CUSTOMER, AND HUNG UP THE PHONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention