BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090610 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93075
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    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

    UNABLE TO PRIME DURING PRIME ALARM TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP PASSED DISPLACEMENT TEST. UNABLE TO PERFORM OCCLUSION, BASIC OCCLUSION AND EXCESSIVE NO DELIVERY ALARMS DUE TO PRIME ANOMALY. MOTOR WAS TESTED. NO MOTOR ANOMALY NOTED. CRACKED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP NOTED DURING 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 DRIVE SUPPORT CAP IS PROTRUDED. CUSTOMER'S FATHER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192946 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAB

    Patients

    Seq Age Sex Outcome Treatment
    1