BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LNAB PRDGM INS V2.1 BL EN

    MDR report key: 1032822 · Received April 21, 2008

    Report

    Report Number
    2032227-2008-00683
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS STATED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE READING WAS REPORTED. IT WAS ALSO STATED THAT THE INSULIN PUMP GAVE A NO DELIVERY ALARM. 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. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LNAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization