BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4241871 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50112
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE IS GETTING AIR BUBBLES IN HER INFUSION SETS. SHE STATED SHE HAS SOME INFUSION SETS FROM LAST YEAR THAT WERE RECALLED, BUT CUSTOMER NEVER GOT A LETTER. SHE HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE THE LAST FOUR DAYS. THERE WERE AIR BUBBLES IN HER INFUSION SET LAST NIGHT AND AIR BUBBLES IN HER RESERVOIR TODAY. CUSTOMER'S BLOOD GLUCOSE THIS MORNING WAS 371 MG/DL. CUSTOMER WAS ADVISED THE INFUSION SETS WERE NOT RECALLED LAST YEAR, BUT SOME RESERVOIRS WERE RECALLED. CUSTOMER'S PRODUCTS WERE NOT AFFECTED. CUSTOMER DECLINED TROUBLESHOOTING FOR AIR BUBBLES BECAUSE SHE HAD DONE IT YESTERDAY. SHE WAS ADVISED IF THERE ARE AIR BUBBLES TO PRIME THEM OUT. REPLACEMENT SUPPLIES WERE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723566 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H9152819

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR