BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123055 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29602
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 18, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. THE PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS. THE PUMP PASSED THE SELF TEST, UNEXPECTED RESTART ERROR TEST, AND OFF NO POWER TESTS. NO UNEXPECTED EXTERNAL RAM CRC OR UNEXPECTED RESTART ERROR ALARMS WERE NOTED. A DISPLAYABLE HISTORY ALARM WAS FOUND IN THE ALARM HISTORY FILE DUE TO A CORRUPTED HISTORY FILE. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    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 CUSTOMER COULD NOT UPLOAD TO CARELINK BECAUSE THE INSULIN PUMP HAS MULTIPLE ALARMS. CUSTOMER HAS NOT USED THE DEVICE FOR SEVERAL MONTHS. NOW THE DOCTOR WANTS CUSTOMER TO GET BACK ON THE DEVICE AND UPLOAD TO CARELINK. A REPLACEMENT IS BEING SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600468 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1