BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    MDR report key: 1211721 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01833
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 STATED THAT HE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 850 MG/DL. THE CUSTOMER WAS TAKEN OFF OF THE INSULIN PUMP BY THE HOSPITAL STAFF, AND AT THE TIME OF THE PHONE CALL THE INSULIN PUMP WAS ALARMING BATTERY OUT LIMIT. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE HIGH PRESSURE TEST PASSED. DURING THE PRIME TEST, IT WAS DISCOVERED THAT THE CUSTOMER WAS NOT PRIMING THE TUBING CORRECTLY. THE CUSTOMER WAS ASSISTED WITH CORRECTLY PRIMING THE INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAS PRDGM INS SK EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization