BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4781022 · Received May 19, 2015

    Report

    Report Number
    2032227-2015-16110
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    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

    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

    THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A BROKEN RESERVOIR TUBE LIP, AND A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BROKEN CASE AND THAT PIECES WERE COMING LOOSE AT THE RESERVOIR. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327078 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1