BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1020659 · Received March 27, 2008

    Report

    Report Number
    3004209178-2008-00217
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE. THE MOTHER REPORTED A BLOOD GLUCOSE READING OF 436 MG/DL DURING THE PHONE CALL. THE CUSTOMER WAS GETTING MULTIPLE NO DELIVERY ALARMS ON THE INSULIN PUMP AND CHANGED THE INFUSION SET AT LEAST FOUR TIMES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALSO PASSED THE PRIME TEST. ADVISED THE MOTHER OF ALTERNATE INSERTION SITES THAT THE CUSTOMER CAN USE. ALSO ADVISED THE MOTHER TO HAVE THE CUSTOMER TRY A DIFFERENT INFUSION SET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention