BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3120919 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93776
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH DETACHED END CAP AND BROKEN BATTERY TUBE THREADS. THE TEST RESERVOIR FITS AND REMOVES PROPERLY IN THE RESERVOIR COMPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP HAS PHYSICAL DAMAGE. CUSTOMER'S BLOOD GLUCOSE READING IS 426 MG/DL. CUSTOMER STATED RESERVOIR CANNOT BE TIGHTEN INTO PLACE AND THE BOTTOM PORTION OF THE INSULIN PUMP IS FALLING OFF. THE BATTERY COMPARTMENT IS ALSO DAMAGED. ADVISED CUSTOMER THAT INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222314 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR