BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4142246 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33369
    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
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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. (B)(4). PLEASE SEE MEDWATCH REPORT # 2032227-2014-33370.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WENT TO THE HOSPITAL AFTER HIS BLOOD GLUCOSE WAS 485 MG/DL AND HE TESTED FOR KETONES, WHICH WERE PRESENT. THE CUSTOMER WAS TREATED WITH INSULIN AT THE HOSPITAL. LEADING UP TO THE HOSPITAL VISIT, THE CUSTOMER HAD WOKEN UP WITH A BLOOD GLUCOSE OF 333 MG/DL, TOOK INSULIN AND BEGAN TO FEEL SICK, LIGHT-HEADED, AND RUN DOWN. THE CUSTOMER WENT BACK ON THE INSULIN PUMP AND STATED WHEN HE REPLACED THE SET, THERE WAS BLOOD IN THE LINE, THERE WAS INSULIN IN THE RESERVOIR COMPARTMENT, AND THE RESERVOIR HAD A CRACK IN IT. THE CUSTOMER STATED HE HAD DROPPED THE RESERVOIR AND THIS MAY HAVE BEEN WHY IT WAS LEAKING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621815 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H8097780

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization