BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3842391 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02676
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S MOTHER REPORTED A HOSPITALIZATION DUE TO DAMAGED INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 222 MG/DL. THE CALLER STATED THE SIGNIFICANT EVENT LEADING TO THE HOSPITALIZATION WAS THE RIPPED OUT INFUSION SET. THE CUSTOMER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE. THE CALLER DECLINED TROUBLESHOOTING THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320697 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization