BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2891782 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-91648
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 641MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT SHE WOKE UP EARLY IN THE MORNING VOMITING, AND HER BLOOD GLUCOSE LEVEL WAS TREATED WITH THE INSULIN PUMP, BUT A FEW HOURS LATER SHE TOOK A MANUAL INJECTION. THEN THE CUSTOMER CONTACTED HER DOCTOR WHO RECOMMENDED GOING TO THE EMERGENCY ROOM. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER TO CORRECT THEM. ADVISED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 53 YR Hospitalization