BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2900549 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-90077
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THAT SHE INJECTED 200.0 UNITS OF INSULIN DURING AN INFUSION SET CHANGE. THE CUSTOMER'S BLOOD GLUCOSE DROPPED TO 17MG/DL, AND SHE DRANK JUICE AND HER BLOOD GLUCOSE WENT UP TO 109MG/DL. THEN THE PARAMEDICS WERE CALLED AND THEY TOOK THE CUSTOMER TO THE HOSPITAL. THE CUSTOMER WAS IN THE INTENSIVE CARE FOR THREE DAYS. THE CUSTOMER STATED THAT SHE WAS NOT DISCONNECTED DURING THE REWIND/PRIME PROCESS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7440 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization