BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6030779 · Received October 14, 2016

    Report

    Report Number
    2032227-2016-30379
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 21, 2013
    Report Date
    October 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. NO EXCESSIVE NO DELIVERY ALARM. HOWEVER, THE INSULIN PUMP WAS UNABLE TO DOWNLOAD DUE TO PROBLEM ISOLATED TO MOTHERBOARD. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 143 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED TO PERFORM PLUNGER PUSH. THE CUSTOMER STATED THAT THE INSULIN DID NOT EXIT DURING PLUNGER PUSH. THE CUSTOMER WAS ADVISED TO ASSEMBLE A NEW INFUSION SET WITH CURRENT RESERVOIR. THE CUSTOMER PERFORMED PLUNGER PUSH AND THE INSULIN DID EXIT THE TUBING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682803 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR