BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2955848 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-90980
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2012
    Report Date
    January 24, 2013
    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 BEING IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE LESS THAN 500MG/DL. THE CUSTOMER WAS VOMITING AND WAS NOT FEELING WELL. THE CUSTOMER STATED THAT SHE ALSO WAS SICK WITH STREP THROAT PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A BATTERY ALARM. THE CUSTOMER HAS NOT BEEN WEARING THE DEVICE SINCE HER ADMISSION. THE CALLER DID NOT HAVE THE TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST, BUT SHE STATED THAT THE DEVICE ALARMED NO DELIVERY TWO WEEKS AGO. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58648 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization