BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1031211 · Received April 17, 2008

    Report

    Report Number
    3004209178-2008-00255
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER'S HUSBAND CALLED STATING THAT THE CUSTOMER WAS HOSPITALIZED WITH A HIGH BLOOD GLUCOSE READING OF 413 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME AND HIGH PRESSURE TESTS. THE HUSBAND ALSO STATED THAT THE CUSTOMER TESTED POSITIVE FOR AN INFECTION WHILE SHE WAS IN THE HOSP. ADVISED THE HUSBAND OF THE EFFECTS THAT AN INFECTION MAY HAVE ON BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization