BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522PNAL PRDGM INS CL EN PW

    MDR report key: 1063307 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01024
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 17MG/DL. THE CUSTOMER STATED THAT PRIOR TO HER ADMISSION SHE ATE AND NOTICED THAT HER BLOOD GLUCOSE WAS LOW. THE CUSTOMER TREATED WITH JUICE, BUT HER GLUCOSE LEVEL WENT DOWN. TROUBLESHOOTING WAS PERFORMED. THE DEVICE PASSED THE DISPLACEMENT TEST AND THE SETTINGS IN THE PUMP WERE CORRECT. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP WAS TAKEN THROUGH A CT SCAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization