BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANCET DEVICE QCKSRTR M4 13L

    MDR report key: 1993048 · Received February 7, 2011

    Report

    Report Number
    2032227-2011-00365
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUICK-SERTER WAS INSPECTED FOR LOCKING AND PROPER OPERATION. THE QUICK-SERTER FAILED DUE TO THE WALLS OF THE INSERTER HAVING EXCESSIVE GLUE FROM THE QUICK-SET TAPE. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2011-80332.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE READING OF 699 MG/DL. THE CUSTOMER ALSO STATED THAT HE HAS HAD TROUBLE WITH THE RELEASE OF THE INSERTION DEVICE. ADVISED THAT THE DEVICE WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET DEVICE QCKSRTR M4 13L ACCESSORIES KZH MEDTRONIC MINIMED MMT-395 MDD0199708

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization