BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974631 · Received August 3, 2014

    Report

    Report Number
    3004209178-2014-89199
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD A CRACKED CASE AT DISPLAY WINDOW CORNER, NO DISPLAY ANOMALY NOTED. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP. NO DAMAGE NOTED ON LCD GLASS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE INSULIN PUMP WAS CRACKED. AN OPERATION TEST AND A SELF TEST WERE COMPLETED NORMALLY. BLOOD GLUCOSE IS UNKNOWN AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452378 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1