BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3230545 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-95757
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 FOR SEVERAL DAYS DUE TO HIGH BLOOD GLUCOSE OF 585MG/DL. THE CUSTOMER STATED WHEN SHE DELIVERS A BOLUS IT WOULD GO BACK TO A SCREEN WITH DASHES FOR HER TO PUT IN THE NUMBERS MANUALLY. ASSISTED THE CALLER TO TURN OFF THE SQUARE BOLUS, AND ADVISED THAT ONCE IT IS TURNED OFF THEN THE DEVICE SHOULD FUNCTION NORMALLY. INSTRUCTED THE CALLER TO CALL BACK IF PROBLEMS PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329555 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization