BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1873679 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-83090
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 REPORTED NOT FEELING WELL. THE CUSTOMER STATED THAT SHE WAS TRYING TO FILL HER RESERVOIR. THE CUSTOMER SOUNDED VERY CONFUSED AND UNRESPONSIVE. THE PARAMEDICS WERE CALLED. MINUTES LATER THE CUSTOMER REACTED AND STATED THAT HER BLOOD GLUCOSE WAS 40 MG/DL. THE CALL WAS DISCONNECTED. ATTEMPTED TO CONTACT THE CUSTOMER AND THE PARAMEDICS ANSWERED THE PHONE. THEY WERE EVALUATING THE CUSTOMER. A SECOND ATTEMPT WAS DONE AND THE CUSTOMER'S BLOOD GLUCOSE WAS 123 MG/DL AT TIME OF THE CALL. THE CUSTOMER STATED THAT SHE TOOK TWO CORTISONE SHOTS TO TREAT HER HIGH GLUCOSE THE NIGHT BEFORE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention