BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFIN QR W/WINGS

    MDR report key: 6103773 · Received November 15, 2016

    Report

    Report Number
    2032227-2016-42294
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    PMA / PMN Number
    K964456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL OF RECEIVING A NO DELIVERY ALARM DURING BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 151 MG/DL. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ASSISTED IN PERFORMING A 5.0 FIXED PRIME AND INSULIN DID EXIT. CUSTOMER WAS ASSITED WITH DELIVERING BOLUS AND CHANGING TIME ON INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755627 POLYFIN QR W/WINGS FPA FPA MEDTRONIC MINIMED MMT-366

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR