BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141990 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33125
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS DUE TO FLATTENED ESCAPE AND ACT BUTTON DOME SWITCHES. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, A BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, A CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 20 MMOL/L. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621654 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1