BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 5994124 · Received October 3, 2016

    Report

    Report Number
    2032227-2016-22939
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. NOTE: 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AN AIR BUBBLE ANOMALY. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 250 MG/DL. THE CUSTOMER STATES THEY HAVE HAD AIR BUBBLE ANOMALIES FOR MONTHS. THE CUSTOMER STATES THEY KEEP THE INSULIN AT ROOM TEMPERATURE. THE CUSTOMER STATES THE PUMP WAS NOT REWOUND WITH A RESERVOIR IN PLACE, OR PREFILLS THE RESERVOIR. THE CUSTOMER SATES THEY DID NOT NOTICE A LEAK OR AIR BUBBLES IN THE SET. HOWEVER THE AIR BUBBLES WERE NOTED, TWO DAYS AFTER DURING SET CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644895 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8550261

    Patients

    Seq Age Sex Outcome Treatment
    1