BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2033946 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-80730
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 FOR HYPOGLYCEMIA, WITH A BLOOD GLUCOSE READING OF 25 MG/DL. THE CUSTOMER'S PERCEIVED REASON FOR EVENT IS THAT HE DID NOT FEEL THE INSULIN PUMP VIBRATE WHEN IT WAS WARNING HIM OF LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HE MAY BE HARD OF HEARING AND COULD NOT HEAR THE ALARMS. IT WAS EXPLAINED TO THE CUSTOMER HOW TO CHANGE ALARMS VIBRATE TO LONG BEEP.

    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 MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization