BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1133349 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-00644
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS ABOVE 500 MG/DL. THE CUSTOMER STATED THAT SHE EXPERIENCED CHEST TIGHTENING AND PARAMEDICS WERE CALLED. CUSTOMER WAS TAKEN TO THE HOSPITAL AND LATER SHE WAS DISMISSED WITH BLOOD GLUCOSE OF 300 MG/DL. THE INFUSION SET WAS NOT CHANGED AND AT TIME OF THE CALL HER BLOOD GLUCOSE WAS 485 MG/DL. REQUESTED CUSTOMER TO CHANGE THE INFUSION SET AND FOUND THAT THE CANNULA WAS BENT. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND HISTORY WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TESTS AND THE DEVICE PASSED THE TESTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization