BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3854493 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85289
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    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

    CUSTOMER REPORTED HOSPITALIZATION FOR EIGHT DAYS DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE WAS OVER 500 MG/DL. THE HOSPITAL SHUT OFF THE INSULIN PUMP. THE BLOOD GLUCOSE WAS 116 MG/DL AT THE TIME OF CALL. CUSTOMER STATED THE BLOOD GLUCOSE ON THE BLOOD GLUCOSE METER WAS NOT SHOWING ON THE INSULIN PUMP. ASSISTED CUSTOMER WITH PROGRAMMING THE METER AND THE TRANSMITTER ID NUMBER. NO OTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332621 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization