BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 6061315 · Received October 27, 2016

    Report

    Report Number
    2032227-2016-38090
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO KEYPAD CONNECTOR UNLOCKED ON THE LCD BOARD. THE KEYPAD TRACES WAS INSPECTED AND NO ANOMALIES NOTED. THE INSULIN PUMP HAD CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON THE LCD WINDOW.

    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 WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THEIR INSULIN PUMP. IT WAS REPORTED THAT THE PUMP HAD UNRESPONSIVE BUTTONS. IT WAS REPORTED THAT THE PUMP WOULD BE REPLACED AND RETURNED FOR ANALYSIS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712826 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715WWP

    Patients

    Seq Age Sex Outcome Treatment
    1