BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2033815 · Received March 17, 2011

    Report

    Report Number
    3004209178-2011-80698
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE LEVELS OF 20 MG/DL. THE CUSTOMER STATED THAT THERE WERE TWO BOLUSES IN THE MIDDLE OF THE NIGHT SHE DID NOT RECALL PROGRAMMING. THE CUSTOMER'S PERCEIVED CAUSE OF EVENT WAS THAT SHE PROGRAMMED THE BOLUSES IN HER SLEEP BECAUSE HER HUSBAND MENTIONED THAT SHE HAD RECEIVED AN ALARM WHILE ASLEEP AND HAD PRESSED THE BUTTONS ON THE INSULIN PUMP. THE PROGRAMMING WAS CORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED REL MMT523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization