BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6125048 · Received November 23, 2016

    Report

    Report Number
    2032227-2016-44083
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 11, 2016
    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 RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC STACK. NO MOISTURE DAMAGE ON THE MOTOR WAS NOTED. THE PUMP WAS UNABLE TO PERFORM SELF-TEST, ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, OPERATING CURRENTS, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST DUE TO BLANK DISPLAY. THE PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED DISPLAY WINDOW AND CRACKED CASE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED OF MOISTURE DAMAGE FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER STATED THAT HE PLAYED FOOTBALL AND TOOK A SHOWER AND TOOK THE PUMP OFF. THE CUSTOMER REPORTED MOISTURE ON THE CORNER OF THE SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776787 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1