BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5111248 · Received September 29, 2015

    Report

    Report Number
    2032227-2015-50489
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND A BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. NO UNLOCKED KEYPAD CONNECTOR NOTED. THE PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    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 WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER FREQUENTLY HAD NO OR INTERMITTENT RESPONSE BY BUTTON PRESS ON THE ACT AND BOLUS BUTTONS. THE PUMP WAS NOT DROPPED OR EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. CUSTOMER IS BEING SENT A REPLACEMENT PUMP. CUSTOMER STATED THAT THE ALARM OCCURRED DURING NORMAL USE. CUSTOMER WAS ASKED VERBALLY AND IN WRITTEN FORM TO RETURN THE PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642418 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1