BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4812970 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61673
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD A PRESENCE OF AIR BUBBLES. THE CALLER STATED THAT THE AIR BUBBLES WERE LARGER THAN THE SIZE OF CHAMPAGNE BUBBLES. THE CUSTOMER'S BLOOD GLUCOSE WAS 315 MG/DL. THE CALLER STATED THAT THE RESERVOIR HAD NOT BEEN REWOUND IN PLACE. THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER HAD ALREADY DISCONNECTED AND PRIMED THE AIR BUBBLES OUT OF THE RESERVOIR. HE ADVISED THAT HE HAD ALLOWED THE INSULIN VIAL TO DEGAS WHILE CHANGING THE SET, BUT THERE HAD NOT BEEN A CHANGE TO THE AIR BUBBLES. HE WAS ADVISED TO EXPELL AIR BY PUSHING THE AIR OUT MANUALLY WITH A PLUNGER. HE WAS ADVISED THAT A POSSIBLE AIR POCKET MAY HAVE BEEN CREATED IN THE RESERVOIR COMPARTMENT BETWEEN THE PISTON AND BOTTOM OF THE 1.8 ML RESERVOIR. HE WAS ADVISED THAT A BOX OF 3.0 ML RESERVOIR WOULD BE SET, AS ALL OTHER TROUBLESHOOTING PROCEDURES HAD BEEN EXHAUSTED EXCEPT FOR THE HIGH PRESSURE TEST; THE CALLER AGREED, STATING HIS WOULD MONITOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355174 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8980134

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR