BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1241065 · Received November 21, 2008

    Report

    Report Number
    2032227-2008-01976
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 489 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE TIME ON THE INSULIN PUMP WAS PROGRAMMED INCORRECTLY. THE CUSTOMER WAS ASSISTED WITH CORRECTLY SETTING THE TIME. THE PRIME TEST PASSED. HOWEVER, THE HIGH PRESSURE TEST FAILED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization