BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAL PRDGM INS V2.1 CL EN

    MDR report key: 1063160 · Received June 20, 2008

    Report

    Report Number
    2032227-2008-01032
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE A WEEK AGO. THE BLOOD GLUCOSE READING WAS 500 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS HIGH IN THE MORNING AND WAS NOT ABLE TO BRING THEM DOWN. THE CUSTOMER FELT SICK, NAUSEA, AND VOMITING. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. CUSTOMER CALLED BACK AND STATED THAT THE PUMP ALARMED SEVERAL TIMES AND FEELS UNCOMFORTABLE WITH THE INSULIN PUMP. THE DEVICE WILL BE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization