BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233582 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48730
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE BASIC OCCLUSION AND DISPLACEMENT TESTS. NO MOTOR ERROR ALARMS WERE NOTED. HOWEVER, THE PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND IT PASSED. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND CASE AT THE RESERVOIR TUBE WINDOW CORNERS, AS WELL AS BROKEN 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 HAD A MULTIPLE MOTOR ERROR ON INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. NO FURTHER TROUBLESHOOTING IS AVAILABLE. THE CUSTOMER WAS ADVISE TO RETURN THE INSULIN PUMP AND WILL BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715314 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWP

    Patients

    Seq Age Sex Outcome Treatment
    1