BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3223108 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95601
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, AND SCRATCHED SCREEN. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE/FLUSH MOTOR SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAS TWO CRACKS ON THE TOP TWO CORNERS. THE BLOOD GLUCOSE READING WAS 150MG/L. ADVISED THE CALLER TO DISCONTINUE THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322918 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR