BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2791831 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07417
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 EXPERIENCING A LOW BLOOD GLUCOSE EPISODE TWO WEEKS AGO AND THE PARAMEDICS WERE CALLED. THE CALLER MENTIONED THAT HE WAS TOLD THE INSULIN PUMP SETTINGS MAY BE INCORRECT OR NEEDING TO BE ADJUSTED SINCE HE IS RECEIVING TOO MUCH INSULIN. THE CUSTOMER STATED THAT THE DEVICE WAS PROGRAMMED BY HIS TRAINER, AND HE DID NOT PROVIDE HIS SETTINGS FOR REVIEW IF THEY ARE CORRECT. THE CALLER DID NOT CONTACT HIS DOCTOR AS SHE IS ON VACATION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention