BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1000450 · Received February 21, 2008

    Report

    Report Number
    2032227-2008-00373
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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

    THE CUSTOMER STATED, THAT SHE WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 40 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO DISCUSS THE EVENT WITH HER DOCTOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention