BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1853310 · Received September 29, 2010

    Report

    Report Number
    2032227-2010-82793
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 532 MG/DL. THE CUSTOMER CHANGED THE ENTIRE INFUSION SET, BUT HER BLOOD GLUCOSE LEVELS CONTINUED TO ELEVATE. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization