BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3000664 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-91788
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 21MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT HER BLOOD GLUCOSE WAS 511MG/DL IN THE MORNING, AND SHE TOOK 20.0 UNITS OF INSULIN. THE CUSTOMER BELIEVES SHE TOOK TOO MUCH INSULIN. REVIEWED THE PROGRAMMING AND IT WAS CORRECT. ADVISED THE CALLER TO CONTACT HER DOCTOR REGARDING HER LOW BLOOD GLUCOSE AND CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104212 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization