BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508GB EA INSULIN BL DE

    MDR report key: 1133261 · Received August 21, 2008

    Report

    Report Number
    2032227-2008-01424
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE CUSTOMER USES THE RESERVOIR FOR TEN DAYS. IT WAS FOUND THAT THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT, AND THE INSULIN PUMP PASSED THE SELF TEST. AFTER REVIEWING THE HISTORY FILES IN THE INSULIN PUMP, IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED AN ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508GB EA INSULIN BL DE INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization