BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974282 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05305
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 NURSE REPORTED THAT THE CUSTOMER RECEIVED A LETTER FROM MEDTRONIC STATING THAT HER INSULIN PUMP MAY HAVE A DEFECT. THE NURSE ALSO STATED THAT THE CUSTOMER SOMETIMES GETS HIGH BLOOD GLUCOSE DURING MORNINGS. THE NURSE WAS INFORMED THAT THE CUSTOMER MAY HAVE RECEIVED A RECALL LETTER. THE BLOOD GLUCOSE READING WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449979 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR