BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4811081 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61232
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 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

    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.

    Additional Manufacturer Narrative · 1

    NO REWIND ANOMALY NOTED. THE INSULIN PUMP PASSED REWIND TEST, BASIC OCCLUSION TEST AND DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. THE MOTOR WAS TESTED OUTSIDE OF THE INSULIN PUMP AND PASSED. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND SHIFTED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS/BASAL. THE DEVICE WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. ALARM HAS OCCURRED ONCE IN THE PAST MONTH. CUSTOMER DOESN'T USE THE SENSOR FEATURE AND WAS UNABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED THE DEVICE NEED TO BE REPLACED AND AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356518 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1