BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFIN QR W/WINGS

    MDR report key: 5663606 · Received May 18, 2016

    Report

    Report Number
    2032227-2016-11143
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    July 15, 2013
    Report Date
    July 17, 2013
    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. 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. THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ALARMED NO DELIVERY ALARM DURING PRIME. CUSTOMER TOOK THE RESERVOIR OUT OF THE DEVICE AND PUSH THE PLUNGER AND NO INSULIN DROPPED FROM THE INFUSION SET. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER AGREED TO RETURN THE INFUSION SET FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318974 POLYFIN QR W/WINGS FPA FPA MEDTRONIC MINIMED MMT-365 50658368

    Patients

    Seq Age Sex Outcome Treatment
    1