BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4842483 · Received June 12, 2015

    Report

    Report Number
    2032227-2015-18956
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    October 13, 2013
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED AND BLEEDING LIQUID CRYSTAL DISPLAY GLASS, CRACKED RESERVOIR TUBE LIP, AND DENTED DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SUSTAINED PHYSICAL DAMAGE AND THAT THE EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 442 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP RIPPED OUT, WENT DOWN A FLIGHT OF STEPS ONTO CONCRETE, BECAME CRACKED ON THE SCREEN, AND NO LONGER WORKED. THE CALLER STATED THAT THE RESERVOIR AND INFUSION SET DID NOT SHOW ANY SIGNS OF DAMAGE. SHE OBSERVED A CRACK ON THE BOTTOM OF THE SCREEN AND STATED THAT THE INSULIN PUMP HAD BEEN DROPPED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386686 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR