BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    MDR report key: 1211729 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-00884
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED, DUE TO DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP HAD ALARMED NO DELIVERY SEVERAL TIMES. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER'S NURSE STATED THAT THE CUSTOMER HAS A COLD WHICH COULD BE CONTRIBUTING TO THE CUSTOMER'S ELEVATED BLOOD GLUCOSE LEVELS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization