BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2842293 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-90877
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 526MG/DL, AND HIS BLOOD GLUCOSE WAS TREATED WITH A BOLUS. THE CUSTOMER EXPERIENCED THIRST AND FREQUENT URINATION. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A LOW RESERVOIR ALARM. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. AFTER RECEIVING THE TUBING CLAMP THE CUSTOMER PERFORMED THE HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization