BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2232583 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-82677
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HAVING HIGH BLOOD GLUCOSE FOR THE PAST THREE DAYS. THE CUSTOMER STATED THAT SHE IS IN THE STORE AND NEEDS THE EMERGENCY SERVICES TO BE CALLED. THE CUSTOMER STATED THAT SHE WAS FEELING NAUSEA AND VERY SLEEPY. THE CUSTOMER STATED THAT SHE HAD TAKEN A MANUAL INJECTION ABOUT 10 MINUTES BEFORE CALLING THE HELPLINE. THE PARAMEDICS ARRIVED TO TAKE CUSTOMER TO THE EMERGENCY ROOM. IT WAS STATED THAT THE CUSTOMER WILL CALL BACK WHEN SHE IS STABLE TO TROUBLESHOOT THE INSULIN PUMP. ATTEMPTED TO CALL THE CUSTOMER BACK SEVERAL TIMES AND LEFT A MESSAGE. THEN THE CUSTOMER CALLED BACK TO THANK US FOR HELPING HER. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization