BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1222037 · Received November 3, 2008

    Report

    Report Number
    3004209178-2008-00918
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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 STATED THAT HE WAS TAKEN BY PARAMEDICS TO THE HOSPITAL DUE TO HYPOGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 26 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE DISPLACEMENT AND PRIME TESTS PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT HE THINKS THE SETTINGS ON THE INSULIN PUMP NEED TO BE ADJUSTED. THE CUSTOMER WAS ADVISED TO CONTACT HIS HEALTHCARE PROVIDER FOR ASSISTANCE ADJUSTING HIS INSULIN PUMP SETTINGS. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization