BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANCET DEVICE MMT-395 QCKSRTR M4 13L

    MDR report key: 1962818 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00107
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR BLOOD GLUCOSE LEVELS AS HIGH AS 604 MG/DL. THE CUSTOMER STATED THAT THE CANNULA WAS BENT WHEN SHE REMOVED THE INFUSION SET, AND FELT THAT IT WAS DUE TO THE INSERTION DEVICE NOT INSERTING WITH THE SAME FORCE AS BEFORE. ADVISED THAT THE INSERTION DEVICE WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET DEVICE MMT-395 QCKSRTR M4 13L ACCESSORIES KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization