BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFIN QR W/WINGS

    MDR report key: 5665066 · Received May 18, 2016

    Report

    Report Number
    2032227-2016-11429
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    January 5, 2014
    Report Date
    January 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    PMA / PMN Number
    K964456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON (B)(6) 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A NO DELIVERY ALARM DURING PRIMING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER PERFORMED PLUNGER PUSH AND THE INSULIN DID NOT EXIT THROUGH THE TUBING. THE INFUSION SET WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320187 POLYFIN QR W/WINGS FPA FPA MEDTRONIC MINIMED MMT-366 50611062

    Patients

    Seq Age Sex Outcome Treatment
    1