BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4142460 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33437
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED A NO DELIVERY ALARM. CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 530 MG/DL AND 600 MG/DL. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION WHICH BROUGHT BLOOD GLUCOSE TO 220 MG/DL AT THE TIME OF CALL. CUSTOMER CHANGED INFUSION SET WHICH SHE BELIEVES SOLVED THE NO DELIVERY ISSUE. CUSTOMER REQUESTED TO RETURN INFUSION SET AND RESERVOIR FOR ANALYSIS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621959 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention