BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4252150 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52833
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 28, 2014
    Report Date
    October 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT IS REPORTED THAT A CUSTOMER CALLED 911 FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS HOSPITALIZED A MONTH BEFORE THE 911 CALL FOR A HIGH BLOOD GLUCOSE LEVEL OF 461 MG/DL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS ASSISTED WITH ASSISTED WITH TROUBLE SHOOTING AND WAS SUCCESSFULLY ABLE TO PUSH HE AIR BUBBLES OUT OF THEIR RESERVOIR. THE CUSTOMER'S INSULIN PUMP WORKS AS DESIGNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738069 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization