BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1873057 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82931
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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'S MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 448 MG/DL. THE MOTHER STATED THAT THE CUSTOMER WAS GETTING NO DELIVERY ALARMS PRIOR TO THE EVENT. THE CUSTOMER CHANGED THE INFUSION SET FOUR TIMES, BUT THE ISSUE WAS NOT RESOLVED UNTIL HE OPENED A NEW BOX OF INFUSION SETS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention