BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5566292 · Received April 10, 2016

    Report

    Report Number
    3004209178-2016-98186
    Event Type
    Malfunction
    Date Received
    April 10, 2016
    Date of Event
    April 6, 2016
    Report Date
    April 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED VIA PHONE CALL INDICATING THAT PATIENT INSULIN PUMP HAD A DRIVE/MOTOR ANOMALY. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN. CUSTOMER'S FATHER REQUESTED TO SEND THE OOW LETTER. THE CUSTOMER FATHER THINKS THAT THE PISTON MAKES STRANGE SOUNDS DURING REWIND PROCESS, THE PUMP IS OOW, WE AGREED TO SEND THE OOW LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222095 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1