BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974068 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88581
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT ALARMED A33 DURING THE PRIME/A33 TEST DUE TO FAULTY FSR. (GOLD) UNIT WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED ON RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW THRU RESERVOIR TUBE AND CRACKED ON BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER IS HAVING ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THE INSULIN PUMP ALARMS DURING PRIME PROCESS. THE BLOOD GLUCOSE READING IS 416 MG/DL. THE INSULIN PUMP WILL BE REPLACED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450766 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR