BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1932912 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83441
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY MULTIPLE TIMES THROUGH THE WEEKEND. THE CUSTOMER ALSO STATED THAT THE INFUSION SET WAS REMOVED IN THE HOSPITAL AND THE CANNULA WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization