BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1032829 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00675
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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. 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 HOSPITALIZED 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 THE BLOOD GLUCOSE LEVELS BEGAN TO ELEVATE. THE CUSTOMER DID GIVE A MANUAL INJECTION, WHICH BROUGHT DOWN THE BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE THE TUBING CLAMP FOR THE HIGH PRESSURE TEST. FOUND THAT THE CUSTOMER USES THE INFUSION SETS FOR MORE THAN THREE DAYS. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET EVERY TWO TO THREE DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization