BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFIN QR W/WINGS

    MDR report key: 5665197 · Received May 18, 2016

    Report

    Report Number
    2032227-2016-11470
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    January 15, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    PMA / PMN Number
    K964456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM DURING PRIME ON THE INSULIN PUMP. CUSTOMER STATED THAT IT WAS A NEW INFUSION SET. CUSTOMER TOOK THE RESERVOIR OUT OF THE PUMP AND PUSHED THE PLUNGER. THERE WERE NO INSULIN DROPS FROM THE INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319438 POLYFIN QR W/WINGS FPA FPA MEDTRONIC MINIMED MMT-365 50652538

    Patients

    Seq Age Sex Outcome Treatment
    1