BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1832999 · Received August 23, 2010

    Report

    Report Number
    2032227-2010-82404
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THE TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL FOR BYPASS SURGERY ON HIS LEG. WHILE IN THE HOSPITAL, THE CUSTOMER BEGAN TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS, RANGING BETWEEN 200 AND 300 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT THE STRESS FROM THE SURGERY PROBABLY CAUSED HIS BLOOD GLUCOSE TO GO HIGH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention