BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3123022 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93823
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST AND ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM NOTED. MOTOR PASSED MOTOR TEST. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW AND A BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND PRIME ALARMS. CUSTOMER'S BLOOD GLUCOSE READING IS 137 MG/DL. CUSTOMER STATES THAT DRIVE SUPPORT CAP IS PROTRUDED. THE DISPLACEMENT TEST FAILED. ADVISED CUSTOMER THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224606 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 64 YR