BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2891768 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-91638
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH A CRACK AND BLEEDING LCD GLASS, BROKEN OFF END CAP AND A CRACK ON RESERVOIR TUBE LIP. THE INSULIN PUMP RECEIVED WITH A CORRODED MOTOR HOME SWITCH.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS DROPPED AND THE PISTON IS OUT OF THE DEVICE. THE MOTHER STATED WHILE THE CUSTOMER WAS EXITING FROM THE BUS, THE INFUSION SET TUBING BECAME SNAGGED AND THE DEVICE FELL. THE CALLER STATED THAT THE INSULIN PUMP WAS CRUSHED BY INCOMING TRAFFIC, AND THE DAMAGE TO THE DEVICE IS A CRACK. ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR