BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3203472 · Received July 2, 2013

    Report

    Report Number
    2032227-2013-02718
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 1, 2012
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CALLED REGARDING THE VOLUNTARY FIELD NOTIFICATION LETTER, AND STATED THAT SHE HAS HAD NO ISSUES WITH THE INSULIN PUMP. HOWEVER, THE CUSTOMER WANTED TO REPORT THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS BACK IN MARCH OF LAST YEAR BECAUSE OF A BENT CANNULA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301399 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization UNOMEDICAL INFUSION SET