BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6670330 · Received June 27, 2017

    Report

    Report Number
    3004209178-2017-57805
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    February 21, 2017
    Report Date
    June 2, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD BLANK DISPLAY DUE TO MISSING BATTERY TUBE SPRING. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF-TEST, OFF NO POWER TEST, UNEXPECTED ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY. PUMP WAS RECEIVED WITH CORRODED BATTERY TUBE AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE SPRING IN THE BATTERY COMPARTMENT GOT DAMAGED BY CORROSION. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452668 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWB

    Patients

    Seq Age Sex Outcome Treatment
    1