BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3013820 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-91979
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 DUE TO LOW BLOOD GLUCOSE OF 31MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HIS WIFE COULD NOT WAKE HIM UP AND THE PARAMEDICS WERE CALLED. THE CALLER STATED THAT HE WAS GIVEN AN INSULIN DRIP AND ORANGE JUICE TO BRING THE BLOOD GLUCOSE VALUE BACK TO NORMAL. THE CUSTOMER MENTIONED THAT HIS KIDNEY MAY HAVE GONE OUT OR SUFFERED SOME ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116273 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization