BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4170416 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37786
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED HER INSULIN PUMP WOULD NOT REWIND AND DELIVER INSULIN. CUSTOMER STATED THAT SHE WAS IN THE INTENSIVE CARE UNIT DUE TO THE INSULIN PUMP. CUSTOMER WAS GIVEN INSULIN PENS TO BRING HOME. CUSTOMER HAD DIABETES KETOACIDOSIS. CUSTOMER'S BLOOD GLUCOSE AT THAT TIME WAS 600-700 MG/DL. CUSTOMER WAS NOT WEARING THE INSULIN PUMP FOR 2 DAYS PRIOR TO HOSPITALIZATION. UNABLE TO CONTINUE THE TROUBLESHOOTING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651314 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 36 YR Hospitalization