BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2760057 · Received March 5, 2007

    Report

    Report Number
    3004209178-2007-00093
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    February 22, 2007
    Report Date
    February 27, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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 WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO REPORTED RECENT NO DELIVERY ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE PRIME TEST. THE TUBING CLAMP WAS NOT AVAILABLE FOR THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAL PRDGM INS V2.1 CL EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization