BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090742 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93083
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED AND PROGRAMMED WITH SEVERAL BOLUSES AND DELIVERED PROPERLY. BOLUS WAS DELIVERED AND RECORDED PROPERLY IN BOLUS HISTORY. ALL OPERATING CURRENTS TESTED WITHIN SPECIFICATION RANGE. NO BLANK DISPLAY NOTED AND NO BLANK DISPLAY NOTED DURING BOLUS DELIVERY. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP NOTED DURING OUR VISUAL INSPECTION.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 IS REPORTED THAT THE INSULIN PUMP STOPPED INSULIN DELIVERY DURING A BOLUS. CHECKED ALARM HISTORY AND DID NOT FIND NO OFF NO POWER ALARMS. CUSTOMER CONCERNED THAT INSULIN PUMP IS STARTING AND STOPPING INSULIN DELIVERY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191333 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWH

    Patients

    Seq Age Sex Outcome Treatment
    1