BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1241069 · Received November 21, 2008

    Report

    Report Number
    2032227-2008-01979
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SPECS. HOWEVER, THE INSULIN PUMP WAS RETURNED WITH A CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED, DUE TO DIABETIC KETOACIDOSIS. THE REPORTED BLOOD GLUCOSE READING WAS 295 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER STATED THAT THE INSULIN PUMP HAS SEVERAL CRACKS NEAR THE RESERVOIR WINDOW. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HIS DIABETES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization