BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515RNAP PRDGM INS PL EN ML PR

    MDR report key: 1031185 · Received April 17, 2008

    Report

    Report Number
    2032227-2008-00657
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 3, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED IN THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED FOR THE EVENT. THE CUSTOMER STATED THAT SHE DID NOT CHANGE THE INFUSION SET WHEN SHE BEGAN TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS. INSTEAD, SHE WENT TO THE EMERGENCY ROOM WHEN SHE BEGAN FEELING ILL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515RNAP PRDGM INS PL EN ML PR INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention