BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4230065 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-36999
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING. NO UNEXPECTED MOTOR ERROR ALARMS NOTED. NO FURTHER TESTING COULD BE PERFORMED DUE TO FAULTY FORCE SENSOR RELAY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED A MOTOR ERROR ALARM. THE MOTHER STATED THE ALARM HAD OCCURRED 4 TIMES. THE INSULIN PUMP WAS NOT DROPPED OR EXPOSED TO A MAGNETIC FIELD. CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 120 MG/DL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645587 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1